BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFIED KUGEL PATCH

    MDR report key: 2249795 · Received September 1, 2011

    Report

    Report Number
    1213643-2011-00412
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K963141
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED TO DAVOL THAT THE RECOIL RING "BROKE" AFTER IT WAS FOLDED AND INSERTED INTO THE PT. THAT MESH WAS REMOVED AND ANOTHER MESH WAS USED TO COMPLETE THE REPAIR. THE MESH WAS RETURNED TO DAVOL AND EVALUATED. THE RING WAS FOUND TO BE COMPLETELY INTACT. THERE WERE KINKS THAT PREVENTED THE RING FROM RECOVERING ITS ORIGINAL SHAPE. HOWEVER, THOSE MAY HAVE BEEN CAUSED BY HANDLING DURING THE PLACEMENT ATTEMPT. THE PRODUCT'S IFU ADDRESSES PROPER HANDLING AND DEPLOYMENT OF THE DEVICE, INCLUDING FOLDING THE DEVICE FOR INSERTION. SPECIFICALLY, IT STATES: "FOLD THE PATCH PARALLEL TO THE OPENING BETWEEN THE STRAPS AND INSERT IT THROUGH THE DEFECT." A MFG REVIEW WAS PERFORMED AND DID NOT FIND EVIDENCE OF A MFG RELATED CAUSE FOR THE CONDITION OF THE PRODUCT. WITH THE INFO PROVIDED, NO CONCLUSION REGARDING WHAT MAY HAVE CAUSED THE CONDITION OF THE MESH CAN BE REACHED. ADD'L 510 K #: K021736.

    Description of Event or Problem · 1

    BASED ON INFO REPORTED TO DAVOL: NI/NI/NI - DURING A VENTRAL HERNIA REPAIR, "THE PLASTIC RING BROKE" AFTER THE DOCTOR FOLDED IT AND INSERTED INTO THE PT. ANOTHER BARD MESH WAS USED INSTEAD FOR THE HERNIA REPAIR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODIFIED KUGEL PATCH FTL DAVOL INC. NA 43FQD354

    Patients

    Seq Age Sex Outcome Treatment
    1 NI