BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 1001077 · Received February 22, 2008

    Report

    Report Number
    2210968-2008-00105
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    October 12, 2007
    Report Date
    January 25, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 02/22/2008. 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 BY THE PATIENT THAT IMMEDIATELY FOLLOWING A TOTAL PELVIC FLOOR REPAIR PROCEDURE IN 2007, WHILE STILL IN THE HOSPITAL, THE PATIENT HAD NO CONTROL OVER HER BLADDER. THE PATIENT CONTINUES TO HAVE URGENCY. THE PATIENT WAS DIAGNOSED WITH A BLADDER INFECTION WITH RETENTION IN 2008, AND WAS GIVEN CIPRO. THE PATIENT EXPERIENCED VAGINAL BLEEDING AT THIS TIME SIMILAR TO A PERIOD. THE PATIENT'S LAST MENSTRUATION WAS IN 2002. THE PATIENT HAD A FOLLOW-UP APPOINTMENT IN 2008.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention