BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH SOFT BARD

    MDR report key: 1190224 · Received October 6, 2008

    Report

    Report Number
    MW5008563
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    January 23, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BARD
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD LEFT SIDE INGUINAL HERNIA REPAIRED LAPAROSCOPICALLY WITH BARD SOFT MESH. HAVE BEEN IN PAIN EVER SINCE. PAIN VARIES TO DULL ACHES TO SHARP PAINS IN INGUINAL AREA WITH RADIATION OF PAINS TO THE HIP, BUTTOCKS AND LEGS. ALSO SHOULD BE NOTED THAT I HAD A RIGHT SIDE INGUINAL HERNIA REPAIRED VIA OPEN SURGERY AND UNKNOWN TYPE MESH IN 1994. NO PAIN AFTER THAT SURGERY -14 YEARS- UNTIL THIS NEW LAP SURGERY OCCURRED, AND NOW THE PAIN MIMICS THE LEFT SIDE. DATES OF USE: 10 MONTHS. DIAGNOSIS OR REASONS FOR USE: INGUINAL HERNIA LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH SOFT BARD NONE FTL BARD HURG1008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R