BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 2943727 · Received January 28, 2013

    Report

    Report Number
    1213643-2013-00033
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 1, 2012
    Report Date
    January 23, 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
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE, WHICH WAS IMPLANTED TEN YEARS AGO, HAS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. APPROXIMATELY TEN YEARS POST IMPLANT THE PT DEVELOPED PAIN IN THE AREA OR REPAIR. UPON EXAM HIS PHYSICIAN THOUGHT HE MIGHT HAVE AN INFECTION AND PRESCRIBED AN ANTIBIOTIC. WHILE NO MEDICAL RECORDS HAVE BEEN PROVIDED TO CONFIRM OR VERITY INFECTION THE PRODUCTS INSTRUCTIONS FOR USE LISTS INFECTION AS A KNOW POSSIBLE ADVERSE REACTION. AND THE WARNING SECTION 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." PRODUCT IDENTIFIERS ARE NOT AVAILABLE, THEREFORE A REVIEW OF THE MFR RECORDS IS NOT POSSIBLE. AT THIS TIME NO CONNECTION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE DAVOL PRODUCT IN QUESTION. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT: PT HAD A LOWER LEFT GROIN INGUINAL HERNIA REPAIR IN (B)(6) 2002. IN THE LAST COUPLE MONTHS HE HAD BEEN EXPERIENCING PAIN WITH MOVEMENT (STAIRS, LIFTING LEG, BENDING, ROTATING TO THE RIGHT) ALONG WITH A BURNING SENSATION AT TIMES. INITIALLY SOUGHT HELP WITH PRIMARY PHYSICIAN AND VISIT WAS DESCRIBED AS MORE OF A VISUAL/PHYSICAL EXAMINATION. PHYSICIAN INDICATED NOTHING PROTRUDING AND ANTI INFLAMMATORY MEDICATION WAS PRESCRIBED. COMPLAINANT INDICATED THAT THIS DID NOT ALLEVIATE THE CONDITIONS HE WAS EXPERIENCING. A SECOND OPINION WAS SOUGHT WITH ANOTHER PHYSICIAN INDICATING NO HERNIA VIA A SIMILAR VISUAL/PHYSICAL EVALUATION AS HIS GENERAL PRACTITIONER. HE WAS REFERRED TO A PAIN SPECIALIST BUT DID NOT GO. SUBSEQUENTLY, HE FOUND OUT THAT THE IMPLANTING PHYSICIAN WAS STILL PRACTICING AND PROCEEDED TO SEE THIS DOCTOR. HE PROVIDED FEEDBACK THAT THE RECEPTIONIST HAD INDICATED THAT THE DOCTOR USES BARD "PREFIX" AND THAT THE PHYSICIAN HAD DESCRIBED THE PRODUCT AS AN "UMBRELLA" LIKE PRODUCT TO ALLOW FOR EXPANSION. THE COMPLAINANT INDICATED THAT THE PHYSICIAN INITIALLY THOUGHT THERE MIGHT BE A POSSIBLE INFECTION AND PRESCRIBED AN ANTIBIOTIC. AT THIS TIME, THIS HAS NOT ALLEVIATED THE CONDITIONS HE IS EXPERIENCING. HE PLANS TO FOLLOW UP AGAIN WITH THIS PHYSICIAN. NO DIAGNOSTIC IMAGING, ETC. HAS BEEN PERFORMED AT THIS TIME. HE INDICATED THAT HE IS STILL FUNCTIONING AND AMBULATORY. NOTHING "EXCRUCIATING" AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38120 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention