BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3202762 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11951
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    August 8, 2011
    Report Date
    June 14, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE LOT STERILIZATION RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY QUALITY CONCERNS AND THE LOT MET ALL RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT SUFFERED BODY MUTILATION COUPLED WITH LIFE THREATENING MASSIVE INFECTIONS, SPLIT OF ABDOMEN, 7 OPEN CAVITY WOUND, COULD SINK 2 FINGERS INSIDE, SEVERAL ADMISSIONS IN EMERGENCY ROOM AND MULTI SURGERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT TRANS-FLAP BREAST RECONSTRUCTION SURGERY ON (B)(6) 2011 AND MESH WAS USED TO SUPPORT THE ABDOMINAL WALL. ONE MONTH LATER SHE DEVELOPED AN INFECTION AND THE ABDOMINAL WOUND DEHISCED. THE WOUND WAS LEFT OPEN TO HEAL AND SHE WAS TREATED WITH ANTIBIOTICS. SHE HAS UNDERGONE SEVERAL SURGERIES. IN (B)(6) 2011 THE MESH WAS REMOVED. THE WOUND FINALLY HEALED IN (B)(6) 2012 LEAVING A LARGE SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300987 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK BPB094

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention