Microneedling Adverse Event Reports in FDA’s MAUDE, by Brand

Byadmin

The FDA’s MAUDE adverse event database holds 60 reports filed under QAI, the product code for microneedling devices, in data last updated by openFDA on September 29, 2026. Searched by brand, Dr. Pen has 2 reports, Dermapen 2, SkinPen 13, and Derminator 3, which are filed under a different product code. None of these numbers says which device is safer.

Why a count is not a ranking

The FDA states this directly. Its page on the database says report data “is not intended to be used either to evaluate rates of adverse events, evaluate a change in event rates over time, or to compare adverse event occurrence rates across devices.” It also says “the submission of an MDR itself does not necessarily demonstrate that the device caused or contributed to the adverse outcome or event,” and that incidence, prevalence or cause “cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use.”

In practice, a count mostly reflects who files. MAUDE takes mandatory reports from manufacturers, importers and device user facilities, and voluntary reports from patients, health professionals and others. A brand whose manufacturer files reports can show a longer record than one that appears only through voluntary reports. Nobody knows how many treatments sit behind any of these numbers, so none of them can be turned into a rate.

All reports under the microneedling code

Of the 60 QAI reports, 37 were filed by manufacturers and 23 were voluntary. They are coded 47 injury, 12 malfunction and 1 other. By year received: 1 in 2020, 2 in 2021, 6 in 2022, 29 in 2023, 5 in 2024, 11 in 2025 and 6 so far in 2026.

The largest group by brand name is ellacor and the Cytrellis micro-coring system: 28 reports, more than any pen. ellacor is a professional system that removes tiny cores of skin (510(k) K252752), and it shares the QAI code with microneedling pens. SkinPen accounts for 13. Every other brand name on the list has three reports or fewer.

Reports by brand

Brand searched Reports Product code Received Filed by Coded as
Dr. Pen 2 QAI Jul 16, 2021; Oct 11, 2023 Voluntary (2) 1 malfunction, 1 injury
Derminator 3 GFE Jan 25, 2018; Mar 6, 2025; Mar 7, 2025 Voluntary (3) 3 injury
Dermapen 2 QAI Jan 4, 2023; May 14, 2025 Voluntary (2) 2 injury
SkinPen 13 QAI Aug 2022 to Jul 2026 Manufacturer (11), voluntary (2) 13 injury

Dr. Pen. Report MW5102615 names a “DR PEN USA MICRONEEDLING DEVICE” and MW5146847 a “DR PEN A6S”. Both list Guangzhou Ekai Electronic Technology Co., Ltd. as manufacturer. No report names the A20 or any other model. Our Dr. Pen brand page covers each model’s regulatory status.

Derminator. All three reports sit under product code GFE, “Brush, Dermabrasion, Powered”, so a search of the microneedling code alone returns none of them. Two name the Derminator 2 (MW5167334 and MW5167381) and one, from 2018, “The Derminator” (MW5074884). The manufacturer field on all three reads “VAUGHTER WELLNESS (OWNDOC.COM)”. See our Derminator 2 review.

Dermapen. One report lists the manufacturer as “DERMA PEN, LLC.” and the other as “UNKNOWN”. Neither names a model.

SkinPen. Eleven of the 13 are manufacturer reports sharing one report-number prefix (3010392991); where the manufacturer field is filled in, it reads Bellus Medical, the company granted the SkinPen Precision’s FDA De Novo in 2018 (DEN160029). Two are voluntary. Two name the Precision Elite. Every Dr. Pen, Dermapen and Derminator report, by contrast, was voluntary, which is one reason these counts can’t be compared. See our SkinPen review.

The narratives in these reports are written by patients, practitioners and companies, and some contain details about individuals. We do not reproduce them.

What it means for buyers

  • A low count is not a clean record. The FDA lists under-reporting as one of the database’s limits.
  • Search by brand and by code. The Derminator reports show that a device can sit outside the code you expect.
  • Read a report as one account. Each one is an unverified description of a single event, useful for seeing what kinds of problems people describe and nothing more.

RF microneedling reports are not covered here: those systems are filed under product code GEI, which mixes them with every other electrosurgical device. See our RF microneedling page.

No company response was sought: this post reports regulator records.

Last updated: October 6, 2026. openFDA searched October 6, 2026; its device adverse event data was last updated September 29, 2026.

Sources

  • FDA, About the Manufacturer and User Facility Device Experience (MAUDE) Database, “Limitations of Medical Device Reports” (checked 2026-10-06): https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/manufacturer-and-user-facility-device-experience-database-maude
  • openFDA device adverse events, product code QAI, counts by brand name (checked 2026-10-06; meta.last_updated 2026-09-29): https://api.fda.gov/device/event.json?search=device.device_report_product_code:QAI&count=device.brand_name.exact
  • openFDA, product code QAI, counts by report source: https://api.fda.gov/device/event.json?search=device.device_report_product_code:QAI&count=report_source_code.exact
  • openFDA, product code QAI, counts by event type: https://api.fda.gov/device/event.json?search=device.device_report_product_code:QAI&count=event_type.exact
  • openFDA, product code QAI, counts by date received: https://api.fda.gov/device/event.json?search=device.device_report_product_code:QAI&count=date_received
  • openFDA, brand “dr pen” (reports MW5102615, MW5146847): https://api.fda.gov/device/event.json?search=device.brand_name:%22dr+pen%22&limit=100
  • openFDA, brand “derminator” (reports MW5074884, MW5167334, MW5167381): https://api.fda.gov/device/event.json?search=device.brand_name:derminator&limit=100
  • openFDA, brand “dermapen” (reports MW5114185, MW5170348): https://api.fda.gov/device/event.json?search=device.brand_name:dermapen&limit=100
  • openFDA, brand “skinpen” (13 reports): https://api.fda.gov/device/event.json?search=device.brand_name:skinpen&limit=100
  • openFDA, ellacor and Cytrellis under QAI (28 reports): https://api.fda.gov/device/event.json?search=device.device_report_product_code:QAI+AND+device.brand_name:(ellacor+OR+cytrellis)&limit=100
  • K252752, ellacor System with Micro-Coring Technology, 510(k) summary: https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252752.pdf
  • FDA De Novo DEN160029, SkinPen Precision System: https://www.accessdata.fda.gov/cdrh_docs/pdf16/DEN160029.pdf