MicroMatrix® MM0060Recalls & reported problems
Acell, Inc. · MicroMatrix® UBM Standard Particulate, 60mg · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00386190001141), received between Apr 13, 2021 and Apr 13, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Off-Label Use1
Patient problems
- Bacterial Infection1
- Fungal Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2021Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method
A PATIENT WHO WAS TREATED WITH MICROMATRIX AT HAIR TRANSPLANT HARVEST SITE, HAS COMPLAINED ABOUT HAVING MULTIPLE EPISODES OF BACTERIAL AND VIRAL INFECTIONS AFTER THE ORIGINAL HAIR TRANSPLANT WOUND SITE HEALED. THE PROCEDURE HAPPENED 9 TO 12 MONTHS AGO. DOCTOR WHO PERFORMED THE PROCEDURE, MIXED THE MICROMATRIX WITH TRIPLE ANTIBIOTIC OINTMENT (BRAND NOT KNOWN) APPLIED IT TOPICALLY TO THE HARVEST SITE. DOCTOR ALSO PROVIDED SOME OF THIS MIXTURE, KNOWN BY NAME "BALM" TO THE PATIENT TO USE THREE TIMES A DAY AT HOME. PATIENT WOUND BED HAS HEALED AND HE IS NO LONGER APPLYING "BALM". HOWEVER, THE PATIENT STARTED HAVING INFECTION APPEAR AT DIFFERENT PLACES OVER HIS BODY (OUTSIDE OF THE ORIGINAL WOUND SITE) IN THE FORM OF PUSTULE. PATIENT SPECIFICALLY MENTIONED ONE OF THOSE INCIDENT WHEN PUSTULE POPPED UP IN HIS LEG AND IT WAS VERY DEBILITATING. THE PAIN WAS EXCRUATING (10 OUT OF 10) AND THE PATIENT WAS ON BED FOR A WEEK. THE PATIENT VISITED DIFFERENT DOCTORS (DERMATOLOGISTS), AND ONE OF THEM PERFORMED BIOPSY ON THE CONTENT FROM THE PUSTULE AND IT CAME POSITIVE FOR FUNGUS (SPECIES NOT DISCLOSED). DOCTOR ALSO CULTURED THE CONTENT FROM THE PUSTULE AND IT CAME POSITIVE FOR BACTERIA (SPECIES N
Patient problems: Bacterial Infection; Fungal Infection
MAUDE report 11657142 ↗
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- Cytal® BMM0710Acell, Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
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- Karl Schumacher TAPE RCWT0001Karl Schumacher Dental Instrument CO., Inc. · Dressing, Wound, Collagen1 recall0 reports
- PriMatrix® 607-005-014Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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