BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 2820636 · Received October 31, 2012

    Report

    Report Number
    1213643-2012-00750
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    October 2, 2012
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K922916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. BASED ON THE INFO PROVIDED IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT REPORTS PAIN AND A "RIPPING" FEELING SINCE AN EPISODE OF UNCONTROLLED COUGHING. ALTHOUGH MEDICAL RECORDS HAVE NOT BEEN PROVIDED THE PT REPORTS A CT WITH NO RELATED FINDINGS TO THE HERNIA REPAIR. THE PT PROVIDED PRODUCT IDENTIFIERS AND A REVIEW OF THE MFG RECORDS WAS PERFORMED AND THERE WAS NO EVIDENCE OF A MFG RELATED CAUSE FOR THE REPORTED EVENT. THE MESH HAS NOT BEEN REPORTED TO BE EXPLANTED. IF ADDITIONAL INFO IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE PT: IT IS ALLEGED THAT HE WAS IMPLANTED ON (B)(6) 2010 AS PART OF A LEFT INGUINAL HERNIA REPAIR. HE INDICATED THAT THE PLUG WAS SECURED SUPERIORLY TO LIGAMENT AND A 2X4 MARLEX MESH WAS PLACED OVER THE FLOOR OF THE INGUINAL CANAL. PT HAS BEEN DOING WELL UNTIL (B)(6) 2012. HE HAD BEEN VERY ACTIVE WITH EXTENSIVE CYCLING AND OTHER ACTIVITIES. HE REPORTED THE CUTTING OF NUMEROUS TREES IN THE SPRING AND HAVING A BOUT OF BRONCHOSPASMS WITH UNCONTROLLED COUGHING. COMPLAINANT DESCRIBED HIS PROBLEMATIC SYMPTOMS OF DISCOMFORT AND PAIN RESULTING FROM SOMETHING "DELAMINATING" AND THERE WAS A "RIPPING" FEELING. HE HAS SEEN A SURGEON DURING TWO VISITS IN (B)(6) 2012, WHO HAS DESCRIBED THE POSSIBILITY OF A SEPARATION OF THE SUBCUTANEOUS LAYERS. PT IS CURRENTLY PRESCRIBED CELEBREX ANALGESIC FOR THE PAIN AS HIS OPTIONS ARE LIMITED DUE TO OTHER HEALTH CONDITIONS AND CONCOMITANT THERAPIES. ADDITIONALLY, HE ICES THE AREA REGULARLY. THE PT REPORTS IMPAIRED DAILY LIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL DAVOL INC NA HUUH1689

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability