MicroMatrix® MM0020Recalls & reported problems

Acell, Inc. · MicroMatrix® UBM Standard Particulate, 20mg · Class U

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00386190001127), received between May 24, 2019 and May 24, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Improper or Incorrect Procedure or Method3
Off-Label Use3
Use of Device Problem3

Patient problems

Itching Sensation3
Rash3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjuryMay 24, 2019Off-Label Use; Use of Device Problem; Improper or Incorrect Procedure or Method; Off-Label Use; Use of Device Problem; Improper or Incorrect Procedure or Method
ON (B)(6) 2019 ACELL RECEIVED NOTIFICATION FROM A NURSE THAT A PATIENT DEVELOPED A RASH, NODULES UNDER SKIN AT SOME INJECTION SITES AND SEVERE ITCHING AFTER A HAIR RESTORATION PROCEDURE WITH MICROMATRIX DILUTED WITH 0.9% BACTERIOSTATIC SODIUM CHLORIDE. THE PROCEDURE WAS DONE ON (B)(6) 2019 AND THE PATIENT REPORTED THE ADVERSE REACTIONS STARTED ON (B)(6) 2019. BENADRYL PROVIDED LITTLE RELIEF AND ON (B)(6) 2019 THE PATIENT WAS PRESCRIBED PREDNISONE (60MG ON DAY ONE, 40MG FOR 5 DAYS). THE PATIENT WAS LAST SEEN ON (B)(6) 2019, AND AS OF (B)(6) 2019 IS DOING BETTER AS PREDNISONE PROVIDED SOME RELIEF.
Patient problems: Itching Sensation; Rash
MAUDE report 8642770 ↗
InjuryMay 24, 2019Off-Label Use; Use of Device Problem; Improper or Incorrect Procedure or Method; Off-Label Use; Use of Device Problem; Improper or Incorrect Procedure or Method
ON (B)(6) 2019 ACELL RECEIVED NOTIFICATION FROM A NURSE THAT A PATIENT DEVELOPED A RASH, NODULES UNDER SKIN AT SOME INJECTION SITES AND SEVERE ITCHING AFTER A HAIR RESTORATION PROCEDURE WITH MICROMATRIX DILUTED WITH 0.9% BACTERIOSTATIC SODIUM CHLORIDE. THE PROCEDURE WAS DONE ON (B)(6) 2019 AND THE PATIENT REPORTED THE ADVERSE REACTIONS STARTED ON (B)(6) 2019. BENADRYL PROVIDED LITTLE RELIEF AND ON (B)(6) 2019 THE PATIENT WAS PRESCRIBED PREDNISONE (60MG ON DAY ONE, 40MG FOR 5 DAYS). THE PATIENT WAS LAST SEEN ON (B)(6) 2019, AND AS OF (B)(6) 2019 IS DOING BETTER AS PREDNISONE PROVIDED SOME RELIEF.
Patient problems: Itching Sensation; Rash
MAUDE report 8642769 ↗
InjuryMay 24, 2019Off-Label Use; Use of Device Problem; Improper or Incorrect Procedure or Method; Off-Label Use; Use of Device Problem; Improper or Incorrect Procedure or Method
ON (B)(6) 2019 ACELL RECEIVED NOTIFICATION FROM A NURSE THAT A PATIENT DEVELOPED A RASH, NODULES UNDER SKIN AT SOME INJECTION SITES AND SEVERE ITCHING AFTER A HAIR RESTORATION PROCEDURE WITH MICROMATRIX DILUTED WITH 0.9% BACTERIOSTATIC SODIUM CHLORIDE. THE PROCEDURE WAS DONE ON (B)(6) 2019 AND THE PATIENT REPORTED THE ADVERSE REACTIONS STARTED ON (B)(6) 2019. BENADRYL PROVIDED LITTLE RELIEF AND ON (B)(6) 2019 THE PATIENT WAS PRESCRIBED PREDNISONE (60MG ON DAY ONE, 40MG FOR 5 DAYS). THE PATIENT WAS LAST SEEN ON (B)(6) 2019 IS DOING BETTER AS PREDNISONE PROVIDED SOME RELIEF.
Patient problems: Itching Sensation; Rash
MAUDE report 8642766 ↗

Device details

UDI-DI	`00386190001127`
Brand	MicroMatrix®
Model	MM0020
Company	Acell, Inc.
Product code	KGN · DRESSING, WOUND, COLLAGEN
Class	Class U
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Jul 21, 2025

Device type (GMDN): Animal-derived wound matrix dressing

A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

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All DRESSING, WOUND, COLLAGEN devices →

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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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