BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3923593 · Received July 9, 2014

    Report

    Report Number
    2210968-2014-08890
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTEROPEXY AND MESH WAS IMPLANTED TO SUPPORT THE UTERUS AND CORRECT THE PROLAPSE. SEVENTEEN MONTHS POST OPERATIVE THE PATIENT DEVELOPED A SMALL BOWEL OBSTRUCTION. A LAPAROTOMY REVEALED A MESH EXPOSURE WITH THE BOWEL CAUGHT UNDERNEATH IT. A SMALL BOWEL RESECTION WAS DONE. THE MESH WAS LEFT IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400384 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK EBR032

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention