BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 2600605 · Received June 1, 2012

    Report

    Report Number
    1213643-2012-00445
    Event Type
    Injury
    Date Received
    June 1, 2012
    Report Date
    May 10, 2012
    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
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAD RECEIVED TO DATE. CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PT INJURY AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. THE PT'S ATTORNEY ALLEGES THE PT WAS TREATED FOR INFECTION, THE WARNING SECTION OF THE IFU STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." A MFG REVIEW THAT INCLUDED REVIEW OF STERILITY RECORDS WAS PERFORMED AND DID NOT FIND EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVAL. IF ADDITIONAL EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED. SEE THE FOLLOWING MDR'S FOR INFO RELATED TO THE OTHER PERFIX PLUGS IMPLANTED ON (B)(6) 2009: 1213643-2012-00442, 1213643-2012-00443, 1213643-2012-00444, 1213643-2012-00446, 1213643-2012-00447, 1213643-2012-00448, 1213643-2012-00449, 1213643-2012-00442.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY: (B)(6) 2009 - THE PT WAS IMPLANTED WITH NINE LARGE BARD PERFIX PLUGS. THE SURGERY WAS TO REPAIR BILATERAL INGUINAL HERNIAS. FOUR LARGE PERFIX PLUGS IN HIS RIGHT GROIN. FIVE PERFIX PLUGS IN HIS RIGHT GROIN. THE PRODUCTS HAVE CAUSED THE PT SEVERE AND PERMANENT BODILY INJURIES, INCLUDING, BUT NOT LIMITED TO, GROIN PAIN, LEG PAIN, INABILITY TO HAVE INTERCOURSE, GENERAL INFECTION, DIFFICULTY URINATING AND BLOATING. ADDITIONALLY, THE PT CURRENTLY SUFFERS FROM SCROTAL ENLARGEMENT AND WILL HAVE TO UNDERGO A SUBSEQUENT CORRECTIVE SURGERY TO REPAIR THE DAMAGE. THE PT HAS EXPERIENCED PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, HAS UNDERGONE MEDICAL TREATMENT AND WILL LIKELY UNDERGO CORRECTIVE SURGERY AND HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUTB1195

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention| S