BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 3190866 · Received June 20, 2013

    Report

    Report Number
    1213643-2013-00267
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 29, 2013
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN F/U DISCUSSION WITH HIS LOCAL REP IT WAS NOTED THAT IN BOTH PROCEDURES THE SURGEON IMPLANTED THE BARD PERFIX PLUG BUT DID NOT REINFORCE THE REPAIR WITH THE FLAT PRE-SHAPED ONLAY THAT IS SUPPLIED WITH THE DEVICE. THE SURGEON WAS MADE AWARE OF THE BENEFITS OF USING THE ONLAY TO SUPPORT THE REPAIR AND BASED ON THAT INFO HE CONCLUDED THAT THE PROBLEMS EXPERIENCED WERE NOT DEVICE RELATED AND THEN WOULD PROVIDE NO ADDITIONAL INFO. NO PRODUCT IDENTIFIERS WERE PROVIDED AND A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED. THE DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL: SURGEON REPORTED THAT HIS PT DEVELOPED A RECURRENCE FOLLOWING HERNIA REPAIR SURGERY WITH A BARD PERFIX PLUG. THE RECURRENCE WAS REPAIRED WITH THE IMPLANT OF ANOTHER BARD PERFIX PLUG AND THE PT AGAIN DEVELOPED A RECURRENCE AT THE SITE. AS THE ISSUE RESULTED IN THE NEED FOR SURGICAL INTERVENTION AN MDR IS FILED TO DOCUMENT THIS EVENT. SEE MDR 1213643-2013-00268 FOR INFO RELATED TO THE OTHER BARD PERFIX PLUG IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281751 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention