BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 1103153 · Received August 8, 2008

    Report

    Report Number
    1213643-2008-00388
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    December 4, 2006
    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

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. WHILE RECURRENCE IS A KNOWN ADVERSE EVENT THAT IS LISTED IN THE IFU, NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVAL OR ADD'L INFO BECOMES AVAILABLE. NOTE: REPORT FROM ATTORNEY INDICATES THAT NO DOCTOR HAD ATTRIBUTED THE EVENT TO THE USE OF OR ANY DEFECT IN THE PERFIX PLUG.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2004 - THE PT UNDERWENT A RIGHT INGUINAL HERNIA REPAIR PROCEDURE WITH IMPLANT OF A PERFIX PLUG. IN 2006 - THE PT REPORTS CHRONIC LOWER RIGHT ABDOMEN PAIN. ON SEVEN MONTHS LATER - THE PT HAD THE PLUG EXPLANTED DUE TO A SMALL HERNIA BEING PRESENT AT THE SITE OF THE ORIGINAL IMPLANT. NO DOCTOR HAS ATTRIBUTED THE ABOVE BODILY INJURIES TO THE USE OF OR ANY DEFECT IN 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 43JND087

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention