BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 1103143 · Received August 8, 2008

    Report

    Report Number
    1213643-2008-00396
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    April 4, 2008
    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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PROD HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A F/U REPORT WHEN/IF PROD IS RETURNED FOR EVAL AND ADD'L INFO BECOMES AVAILABLE. REFERENCE MEDWATCHES 1213643-2007-00636 & 1213643-2008-00397 FOR INFO RELATED TO THE PERFIX MESHES IMPLANTED IN 2005.

    Description of Event or Problem · 1

    IN 2006, THE PT UNDERWENT A RECURRENT RIGHT INGUINAL HERNIA REPAIR PROCEDURE WITH IMPLANT OF A PERFIX PLUGS. PREVIOUSLY IMPLANTED MESH PLUGS WERE NOT REMOVED. ON SIX MONTHS LATER, THE PT UNDERWENT A DIAGNOSTIC LAPAROSCOPY. THE MESH PLUGS WERE NOT REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other