BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 1855144 · Received September 30, 2010

    Report

    Report Number
    2210968-2010-01217
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    May 1, 1998
    Report Date
    August 31, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INCISIONAL (C-SECTION) HERNIA REPAIR WITH MESH IN 1998. THE PATIENT EXPERIENCED PROBLEMS WITHIN 24-48 HOURS AFTER THE INITIAL HERNIA REPAIR SURGERY. POST-OPERATIVE SYMPTOMS OF FEVER, BLEEDING AND LEAKING (NOT DIRECTLY FROM INCISION), FAINTING, AND WEAKNESS OCCURRED. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND ASPIRATION. THESE SYMPTOMS ABATED BUT BOWEL AND BLADDER SYMPTOMS FOLLOWED OVER THE NEXT TWELVE YEARS INCLUDING RECTAL FISTULAS, URETHRAL SCAR TISSUE, BLADDER AND PELVIC FLOOR ISSUES SINCE THE SURGERY. MOST RECENTLY, A FEW MONTHS AGO, REDNESS AND ABSCESSES NEAR INCISION OCCURRED. CURRENTLY, THE PATIENT IS RECEIVING PHYSICAL THERAPY FOR BLADDER STRICTURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention