BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 1103150 · Received August 8, 2008

    Report

    Report Number
    1213643-2008-00385
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    March 19, 2002
    Report Date
    July 11, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K922916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: REPORT FROM ATTORNEY INDICATES THAT NO DOCTOR HAS ATTRIBUTED THE EVENT TO THE USE OF OR ANY DEFECT IN THE PERFIX PLUG.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2002 - DURING REPAIR OF AN INCISIONAL HERNIA, A PERFIX PLUG MESH WAS IMPLANTED INTO THE PT. IN 2004 - PRESENT - PT HAS EXPERIENCED CONTINUOUS PAIN, PINCHING, BINDING; SEXUAL DYSFUNCTION, DUE TO PAIN IN ABDOMINAL AREA. DOCTOR HAS ADVISED THAT THE PT SHOULD HAVE THE MESH REMOVED DUE TO THE FACT THAT THERE IS A VISIBLE PROTRUSION COUPLED WITH CHRONIC PAIN STEMMING FROM THE SITE OF THE IMPLANT. NO DOCTOR HAS ATTRIBUTED THE ABOVE BODILY INJURIES TO THE USE OF THE PERFIX PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43AMD124

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other