BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 3070722 · Received April 15, 2013

    Report

    Report Number
    1213643-2013-00149
    Event Type
    Injury
    Date Received
    April 15, 2013
    Report Date
    March 26, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K92916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE ATTORNEY'S REPORT ALLEGES THAT THE PT WAS IMPLANTED WITH A PERFIX PLUG FOR REPAIR OF A FEMORAL HERNIA. NO SPECIFIC DEVICE FAILURE HAS BEEN ALLEGED AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO. 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 HAS BEEN RETURNED FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADD'L EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY. ON (B)(6) 2005, THE PT WAS IMPLANTED WITH A BARD PREFIX PLUG DURING RIGHT FEMORAL HERNIA REPAIR. THE PT WAS ALSO IMPLANTED WITH NON-BARD DEVICES IN THE PELVIC AREA FOR UNSPECIFIED REASONS. THE ATTORNEY'S REPORT ALLEGES ADD'L MEDICAL/SURGICAL TREATMENT, NERVE DAMAGE, PERMANENT INJURY, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160740 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43APD454

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability