BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR

    MDR report key: 1081693 · Received July 24, 2008

    Report

    Report Number
    2210968-2008-00595
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 23, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 07/23/2008. HEMATOMA OCCURRED - INFECTION OCCURRED - CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A PELVIC FLOOR REPAIR PROCEDURE IN 2008. THE PT DEVELOPED AN INFECTION OF A HEMATOMA ON THE SAME DAY. THE PT WAS TREATED WITH ANTIBIOTIC THERAPY AND ANTI-INFLAMMATORY THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT +M PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3108953

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R