BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD ALIGN HALO TO -BRD500HL- SLING GU/GYN

    MDR report key: 2771676 · Received September 25, 2012

    Report

    Report Number
    MW5027117
    Event Type
    Injury
    Date Received
    September 25, 2012
    Date of Event
    December 10, 2010
    Report Date
    September 25, 2012
    Manufacturer
    BARD
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    VAGINAL SLING/MESH/TAPE IMPLANTED ON (B)(6) 2010 FOR SUI. HAVE NEVER BEEN ABLE TO URINATE NORMALLY SINCE PROCEDURE. WAS UNABLE TO URINATE ON MY OWN SO WAS SENT HOME WITH A FOLEY CATHETER IN PLACE UNTIL ABLE TO SEE SURGEON IN OFFICE. HAVE NEVER BEEN ABLE TO FULLY EMPTY BLADDER. AM NOW EXPERIENCING EXCRUCIATING PAIN WITH URINATION, BUT NOT ALWAYS. PAINFUL INTERCOURSE -FIRST OPPORTUNITY FOR SAME OCCURRED WITHIN LAST FEW DAYS SO UNAWARE UNTIL THEN OF PAIN. ALSO HAD SOME BLEEDING WITH INTERCOURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ALIGN HALO TO -BRD500HL- SLING GU/GYN BLADDER SLING FTL BARD HUUIO181

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention| S