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MicroMatrix® MM1000Recalls & reported problems

Acell, Inc. · MicroMatrix® UBM Standard Particulate, 1000mg · Class U

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 00386190001202), received between Aug 30, 2018 and Aug 30, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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

  • Use of Device Problem3

Patient problems

  • No Consequences Or Impact To Patient3
  • No Known Impact Or Consequence To Patient3

Recent adverse event reports

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

  • InjuryAug 30, 2018Use of Device Problem; Use of Device Problem

    ON 7/31/2018, ACELL, INC. BECAME AWARE A PATIENT EXPERIENCED HEMATOMA FORMATION AFTER APPLICATION OF ACELL DEVICES ON (B)(6) 2018 FOR AN ACUTE WOUND. THE MALE PATIENT WAS IN A MOTORCYCLE ACCIDENT ABOUT 4 WEEKS EARLIER WHERE HE INCURRED A LARGE DE-GLOVING INJURY WITH EXPOSED BONE AND TENDON ON HIS LEFT LEG. WOUND VAC HAD BEEN UTILIZED FOR SEVERAL WEEKS PRIOR TO THE SURGERY ON (B)(6) 2018. DURING THE SURGERY MICROMATRIX WAS FOCUSED MAINLY ON THE EXPOSED AREAS: BONE, TENDON AND UNDERMINED AREAS; VERSAJET WAS ALSO USED ON THE WOUND. THE PATIENT HAS AN EXTERNAL FIXTURE DEVICE ON HIS LEG AND ONGOING WOUND VAC THERAPY.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 7832465 ↗
  • InjuryAug 30, 2018Use of Device Problem; Use of Device Problem

    ON(B)(4) 1820, ACELL, INC. BECAME AWARE A PATIENT EXPERIENCED HEMATOMA FORMATION AFTER APPLICATION OF ACELL DEVICES ON (B)(6) 2018 FOR AN ACUTE WOUND. THE MALE PATIENT WAS IN A MOTORCYCLE ACCIDENT ABOUT 4 WEEKS EARLIER WHERE HE INCURRED A LARGE DE-GLOVING INJURY WITH EXPOSED BONE AND TENDON ON HIS LEFT LEG. WOUND VAC HAD BEEN UTILIZED FOR SEVERAL WEEKS PRIOR TO THE SURGERY ON (B)(6) 2018. DURING THE SURGERY MICROMATRIX WAS FOCUSED MAINLY ON THE EXPOSED AREAS: BONE, TENDON AND UNDERMINED AREAS; VERSAJET WAS ALSO USED ON THE WOUND. THE PATIENT HAS AN EXTERNAL FIXTURE DEVICE ON HIS LEG AND ONGOING WOUND VAC THERAPY.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 7832457 ↗
  • InjuryAug 30, 2018Use of Device Problem; Use of Device Problem

    ON (B)(6) 2018, ACELL, INC. BECAME AWARE A PATIENT EXPERIENCED HEMATOMA FORMATION AFTER APPLICATION OF ACELL DEVICES ON (B)(6) 2018 FOR AN ACUTE WOUND. THE PATIENT WAS IN A MOTORCYCLE ACCIDENT ABOUT 4 WEEKS EARLIER WHERE HE INCURRED A LARGE DE-GLOVING INJURY WITH EXPOSED BONE AND TENDON ON HIS LEFT LEG. WOUND VAC HAD BEEN UTILIZED FOR SEVERAL WEEKS PRIOR TO THE SURGERY ON (B)(6) 2018. DURING THE SURGERY MICROMATRIX WAS FOCUSED MAINLY ON THE EXPOSED AREAS: BONE, TENDON AND UNDERMINED AREAS; VERSAJET WAS ALSO USED ON THE WOUND. THE PATIENT HAS AN EXTERNAL FIXTURE DEVICE ON HIS LEG AND ONGOING WOUND VAC THERAPY.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 7832319 ↗

Other DRESSING, WOUND, COLLAGEN devices

All DRESSING, WOUND, COLLAGEN devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.