BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARLEX PATCH WITH BARD PERFIX PLUG

    MDR report key: 1000007 · Received February 12, 2008

    Report

    Report Number
    MW5005532
    Event Type
    Injury
    Date Received
    February 12, 2008
    Date of Event
    June 30, 2005
    Report Date
    February 12, 2008
    Manufacturer
    C. R. BARD INC. / DAVOL INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INTRACTABLE PAIN FOLLOWING RIGHT INGUINAL HERNIA REPAIR WITH EXTRA LARGE MARLEX PATCH AND A BARD PERFIX PLUG. DEBILITATING RIGHT GROIN PAIN ALONG THE INGUINAL LIGAMENT UP TOWARD THE ANTERIOR SUPERIOR ILIAC SPINE. PAIN RADIATES FROM THE ANTERIOR SUPERIOR ILIAC SPINE INTO THE SCAR AND TOWARD THE SCROTUM. THERE IS TENDERNESS IN THE TESTICLE WITH PAIN IN THE MEDIAL THIGH SKIN, THE SKIN AROUND THE SCROTUM, AND ALONG THE COURSE OF THE INGUINAL LIGAMENT. THERE WAS SIGNIFICANT BRUISING AND SWELLING OF THE RIGHT GROIN, UPPER THIGH, AND SCROTUM IMMEDIATELY FOLLOWING SURGERY. PAIN MGMT WITH LIDOCANE PATCHES AND TRIGGER POINT INJECTIONS FAILED TO BE EFFECTIVE. NERVE BLOCK PRODUCED IMMEDIATE, BUT TEMPORARY RELIEF. DATES OF USE: 2005 - 2008. DIAGNOSIS OR REASON FOR USE: RIGHT INGUINAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARLEX PATCH WITH BARD PERFIX PLUG BARD PERFIX PLUG FTL C. R. BARD INC. / DAVOL INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Disability