BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 2782142 · Received October 3, 2012

    Report

    Report Number
    1213643-2012-00659
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    March 29, 2004
    Report Date
    September 11, 2012
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K922916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, NO DEFINITIVE CONCLUSIONS CAN BE MADE. THE PATIENT UNDERWENT REPAIR OF RIGHT INGUINAL HERNIA WITH IMPLANT OF A PERFIX PLUG. NEARLY THREE YEARS POST IMPLANT THE PATIENT UNDERWENT REPAIR OF A LEFT INGUINAL HERNIA AND AT THAT TIME THE RIGHT SIDE WAS EXPLORED. THE PERFIX PLUG WAS NOTED TO BE PARTIALLY EXPLANTED. THERE IS NO INDICATION AS TO WHY THE RIGHT SIDE WAS EXPLORED OR THE REASON FOR THE MESH BEING PARTIALLY EXPLANTED. PRODUCT IDENTIFIERS HAVE NOT BEEN PROVIDED THEREFORE A MANUFACTURING REVIEW IS NOT POSSIBLE. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVALUATION. WITH THE CURRENTLY AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN. SEE MDR 1213643-2012-00592 FOR INFORMATION RELATED TO THE KUGEL PATCH IMPLANTED ON (B)(6) 2004.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: (B)(6) 2011 - PATIENT UNDERWENT RIGHT INGUINAL HERNIA REPAIR WITH IMPLANT OF PERFIX PLUG AND A NON-BARD MESH. PERFIX PLUG WAS PLACED IN INTERNAL RING TO PREVENT FUTURE INDIRECT INGUINAL HERNIA, AND ONLAY MESH WAS SEWN. (B)(6) 2004 - PATIENT UNDERWENT REPAIR OF LEFT INGUINAL HERNIA WITH IMPLANT OF KUGEL PATCH. IN RIGHT INGUINAL AREA, PARTIAL REMOVAL OF THE PERFIX PLUG. ILIOINGUINAL NERVE WAS TRANSECTED PROXIMALLY. (B)(6) 2010 - PATIENT REPORTS HAVING A WORK INJURY CAUSING CHRONIC INTERMITTENT PAIN IN RIGHT INGUINAL AREA. LEFT INGUINAL HERNIA RECURRENCE DISCOVERED. (B)(6) 2011 - PATIENT UNDERWENT REPAIR OF RECURRENT LEFT INGUINAL HERNIA. UPON EXPLORATION IT WAS NOTED THAT THE KUGEL PATCH WAS "BALLED-UP" AND HAD FOLDED ON ITSELF. THE KUGEL PATCH WAS EXCISED AND A COMPOSIX KUGEL MESH WAS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention