MicroMatrix® MM0030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00386190001134), received between Jul 27, 2017 and Aug 31, 2018 — classified as 2 injuries.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2018Off-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) 2018 ACELL RECEIVED NOTIFICATION FROM A NURSE THAT A PATIENT DEVELOPED LUMPS AT THE INJECTION SITES AND EXPERIENCED ITCHING AFTER CONDUCTING A HAIR RESTORATION PROCEDURE WITH MICROMATRIX AND PLATELET RICH PLASMA (PRP). THE LUMPS ARE DESCRIBED AS VARYING IN SIZE, RAISED AND PAINFUL TO THE TOUCH. THE PROCEDURE WAS DONE ON (B)(6) 2018 AND PATIENT DEVELOPED ADVERSE REACTIONS STARTING THE SAME DAY. BENADRYL PROVIDED RELIEF OF THE ITCHING, IBUPROFEN PROVIDED SOME MINOR PAIN RELIEF AND DOSE PACK OF PREDNISONE WAS PRESCRIBED. PATIENT WAS LAST SEEN ON (B)(6) 2018. THE LUMPS ON HEAD HAVE IMPROVED AND ARE SMALLER IN SIZE, PREDNISONE PROVIDED SOME RELIEF. PATIENT HAS AN AUTOIMMUNE DISEASE SCLERODERMA.

  Patient problems: Itching Sensation; Swelling

  MAUDE report 7838808 ↗
• InjuryJul 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 PHYSICIAN INJECTED MIXTURE OF PLATELET RICH PLASMA AND MICROMATRIX POWDER INTO THE SCALP AREA. ON (B)(6) 2017 PATIENT RETURNED TO THE CLINIC TO VOICE SOME CONCERNS, AND WAS REFERRED TO A DERMATOLOGIST. PATIENT STATED SHE WAS HAVING A REACTION AND DESCRIBED THE AREA WAS VERY PAINFUL, THERE WAS SORENESS, BUT NO REDNESS IN AREA, HER HAIR SEEMED "ELECTRIC" AND BEGAN TO FALL OUT. PATIENT CLAIMED NO ALLERGIES TO PORK OR OTHER SUBSTANCES. DERMATOLOGIST RULED OUT LICHENOID REACTION. ON (B)(6) 2017 PATIENT RETURNED TO THE CLINIC WITH CONTINUED COMPLAINTS, AND HAD SKIN TEST PERFORMED BY ORIGINAL TREATING PHYSICIAN. ON (B)(6) 2017 ORIGINAL TREATING PHYSICIAN NOTED THAT PATIENT HAD A MILDLY POSITIVE REACTION WHICH WAS DESCRIBED AS "RED AND RAISED AREA" BY THE PATIENT. PER THE PATIENT, HER PRIMARY CARE PHYSICIAN PRESCRIBED ANTIHISTAMINES, AND BENADRYL FOR SLEEP. ON (B)(6) 2017 IT WAS NOTED BY ORIGINAL TREATING PHYSICIAN THAT THE REDNESS WAS RESOLVED, AND, BASED ON PAST HISTORY OF DULOXETINE USE DULOXETINE WAS RESTARTED.

  Patient problems: Headache; Swelling

  MAUDE report 6748995 ↗