BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX

    MDR report key: 5414566 · Received February 6, 2016

    Report

    Report Number
    2530154-2016-00001
    Event Type
    Injury
    Date Received
    February 6, 2016
    Date of Event
    December 22, 2015
    Report Date
    February 5, 2016
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    OXH
    PMA / PMN Number
    K094061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. THEREFORE, THE INVESTIGATION IS LIMITED TO REVIEW OF THE LOT HISTORY RECORDS. THE LOT HISTORY RECORDS INDICATE THAT THE DEVICES IN THE LOT MET ALL PRE-DETERMINED ACCEPTANCE CRITERIA. SEROMA AND INFECTION ARE KNOWN COMPLICATIONS THAT HAVE BEEN REPORTED IN THE LITERATURE TO OCCUR IN UP TO 20% OF IMPLANT-BASED BREAST RECONSTRUCTIONS. OUTCOME INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS PROVIDED, IT WILL BE REPORTED IN A FOLLOW-UP REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    A FEMALE PATIENT HAD BILATERAL, NIPPLE-SPARING MASTECTOMY FOLLOWED BY IMMEDIATE BREAST RECONSTRUCTION WITH BILATERAL MESO BIOMATRIX AND TISSUE EXPANDER IMPLANTATION. AT APPROXIMATELY 3 WEEKS POST-OPERATIVE, SHE REQUIRED ASPIRATION OF BILATERAL SEROMA AND BEGAN A 5 DAY COURSE OF ORAL ANTIBIOTICS. TWO DAYS LATER, MILD REDNESS WAS OBSERVED ON THE LOWER POLE OF THE LEFT BREAST. AT APPROXIMATELY 4 WEEKS POST-OPERATIVE, THE SEROMA RECURRED IN THE LEFT BREAST REQUIRING ASPIRATION. TWO DAYS LATER, A 'SLIGHT LEAK' WAS OBSERVED ALONG WITH CONTINUED REDNESS OF THE LEFT BREAST. INTRAVENOUS ANTIBIOTICS WERE STARTED AND SHE WAS SUBSEQUENTLY TAKEN TO THE OPERATING THEATER FOR SURGICAL EXPLORATION, WASHOUT AND VANCOMYCIN IRRIGATION OF THE LEFT BREAST. SHE WAS DISCHARGED 3 DAYS LATER AND BEGAN A 7 DAY COURSE OF ORAL ANTIBIOTICS. DURING THE FOLLOWING TWO WEEKS, THE LEFT BREAST SEEMED TO BE HEALING FINE. HOWEVER, REDNESS AND SWELLING OF THE LEFT BREAST RECURRED APPROXIMATELY ONE MONTH AFTER THE SURGICAL EXPLORATION. THE TISSUE EXPANDER AND MESO BIOMATRIX WERE SUBSEQUENTLY EXPLANTED FROM THE LEFT BREAST. AS OF THE DATE OF THIS REPORT, THE OUTCOME IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72678 MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY OXH DSM BIOMEDICAL 30055-06 C5184

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention