BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX

    MDR report key: 5518408 · Received March 22, 2016

    Report

    Report Number
    2530154-2016-00007
    Event Type
    Injury
    Date Received
    March 22, 2016
    Date of Event
    August 25, 2015
    Report Date
    March 22, 2016
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    OXH
    PMA / PMN Number
    K094061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL NUMBER AND LOT NUMBER OF THE DEVICE HAVE BEEN REQUESTED, BUT HAVE NOT BEEN PROVIDED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE COMPLICATIONS CAN NOT BE DETERMINED. IF ADDITIONAL INFORMATION IS PROVIDED BY THE REPORTER, IT WILL BE SUBMITTED IN A FOLLOW-UP REPORT. DEVICE WAS NOT EXPLANTED.

    Description of Event or Problem · 1

    THE HAD RIGHT, UNILATERAL, NIPPLE-SPARING MASTECTOMY FOLLOWED BY IMMEDIATE, SINGLE-STAGE BREAST RECONSTRUCTION WITH 435CC SILICONE BREAST IMPLANT PLACEMENT. MESO BIOMATRIX WAS IMPLANTED IN RIGHT BREAST AS PART OF THE RECONSTRUCTION. AT 1 WEEK POST-OPERATIVE, ECCHYMOSIS WAS OBSERVED ON THE LOWER HALF OF THE BREAST UP TO THE NIPPLE. THE NIPPLE WAS NOTED AS BEING VITAL. THERE WERE NO SIGNS OF INFECTION. AT 2 WEEKS POST-OPERATIVE, THE BREAST WAS NOTED AS SOFT, BUT THE NIPPLE WAS COLD AND DARK. BELOW THE NIPPLE WAS A COLD AND DARK AREA WITH ALMOST NO REFILL. THE PATIENT WAS REFERRED FOR HYPERBARIC OXYGEN TREATMENT AND GIVEN ORAL ANTIBIOTICS. AT 3 WEEKS POST-OPERATIVE, THERE WERE NO SIGNS OF IMPROVEMENT. THE PATIENT WAS TIRED AND ANXIOUS, BUT HAD NO SIGNS OF INFECTION. BETADINE GAUZE WAS PLACED AND SHE CONTINUED ON ANTIBIOTICS. AT 3.5 WEEKS POST-OPERATIVE, THE WOUND DEHISCED, THE MESH WAS VISIBLE AND 'DIRTY' FLUID DRAINED FROM THE WOUND. SHE HAD NO FEVER. THERE WAS REDNESS ON THE LOWER HALF OF THE BREAST. SO, THE IMPLANT AND NECROTIC SKIN WERE REMOVED. THE POCKET WAS CLEANSED, A DRAIN WAS PLACED AND THE WOUND WAS CLOSED IN LAYERS. CULTURES SHOWED NO GROWTH. THE COMPLICATIONS HAVE RESOLVED AND THE PATIENT IS REPORTEDLY HEALTHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172078 MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY OXH DSM BIOMEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention