BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 1881046 · Received October 19, 2010

    Report

    Report Number
    2210968-2010-01338
    Event Type
    Injury
    Date Received
    October 19, 2010
    Report Date
    September 26, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). URINARY TRACT INFECTION. CONCLUSIONS: 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 AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE ON AN UNK DATE. BY THE TWO MONTH FOLLOW-UP VISIT, THE PT HAD DEVELOPED A URINARY TRACT INFECTION. ORAL ANTIBIOTICS WERE PRESCRIBED AND THE URINARY TRACT INFECTION RESOLVED.

    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 79 YR Required Intervention