BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFIED KUGEL PATCH

    MDR report key: 2925533 · Received January 10, 2013

    Report

    Report Number
    1213643-2013-00011
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 12, 2012
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K963141/K021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING ARE THE RESULTS OF THE EVALUATION CONDUCTED ON THE MODIFIED KUGEL PATCH THAT WAS RETURNED AFTER THE USER, PRIOR TO USE ON A PATIENT, ALLEGED TO HAVE FOUND THE RECOIL RING DAMAGED AT THE WELDED SITE AND PROTRUDING FROM THE MESH. THE RING IS OBSERVED TO BE INTACT. THERE IS VISUAL EVIDENCE OF A COMPLETE WELD ALONG THE ENTIRE LENGTH OF THE OVERLAP LENGTH. ONE END OF THE WELD IS UNATTACHED TO THE BASE MONOFILAMENT, AT THIS TIME CAUSING A GAP. THERE IS A KINK IN THE RING CLOSE TO THE LOCATION WHERE THE GAP INITIATES. BASED ON THIS EVALUATION IT APPEARS THAT THE DEVICE WAS SUBJECTED TO STRESS AT SOME POINT, AFTER ASSEMBLY WHICH DAMAGED THE DEVICE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME, AS IT IS NOT KNOWN WHEN, AFTER ASSEMBLY, THE DEVICE WAS EXPOSED TO STRESS. A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED AND THE LOT WAS PRODUCED WITH NO ANOMALIES, NO EVIDENCE WAS FOUND OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL: ON (B)(6) 2012 THE USER FOUND THAT THE RECOIL RING OF THE MODIFIED KUGEL HERNIA PATCH WAS DAMAGED AT WELDED SITE AND PROTRUDED FROM THE MESH. THE ISSUE WAS NOTED AFTER IT WAS REMOVED FROM THE PACKAGE PRIOR TO USE ON THE PATIENT. ANOTHER DEVICE WAS USED AND THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13803 MODIFIED KUGEL PATCH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUWE0959

    Patients

    Seq Age Sex Outcome Treatment
    1