BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2123863 · Received June 14, 2011

    Report

    Report Number
    2210968-2011-00762
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). URINARY TRACT INFECTION. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT REPORT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS USED. SINCE THAT TIME, MARITAL RELATIONS HAVE BEEN IMPOSSIBLE AND FREQUENT URINARY TRACT INFECTIONS HAVE OCCURRED REGULARLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC FTL ETHICON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention