BEUDAMED
    FDA Adverse Event Other Summary report: N

    KUGEL PATCH

    MDR report key: 2358236 · Received November 30, 2011

    Report

    Report Number
    1213643-2011-00695
    Event Type
    Other
    Date Received
    November 30, 2011
    Date of Event
    April 26, 2007
    Report Date
    December 22, 2008
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K963141
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS EVENT WAS ORIGINALLY REPORTED TO DAVOL AS A RECALLED COMPOSIX KUGEL MESH; THEREFORE, DAVOL ORIGINALLY REPORTED THIS EVENT TO THE FDA IN ACCORDANCE WITH RAE 2008004. SUBSEQUENTLY, DAVOL HAS RECEIVED ADD'L EVENT INFO INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE WE ARE SUBMITTING THIS MDR BASED ON THE ADD'L INFO RECEIVED. CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT. THE PT IS REPORTED TO HAVE DEVELOPED A RECURRENCE, WHICH IS STATED AS A POSSIBLE ADVERSE REACTION IN THE PRODUCT'S INSTRUCTION FOR USE. THE MEDICAL RECORDS NOTE THAT THE MESH HAD CONTRACTED. WHILE NO SAMPLE HAS BEEN RETURNED FOR EVAL, A MFG REVIEW WAS PERFORMED AND DID NOT FIND EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. WE HAVE CONTACTED THE INITIAL REPORTER TO OBTAIN ADD'L INFO AND TO HAVE THE DEVICE RETURNED, WITHOUT ADD'L INFO, NO CONCLUSION CAN BE DRAWN. REFER TO MDR 1213643-2011-00696 FOR INFO REGARDING THE COMPOSIX L/P IMPLANTED ON (B)(6) 2007.

    Description of Event or Problem · 1

    BASED ON REVIEW OF MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: ON (B)(6) 2007, RIGHT MID-LOWER ABDOMINAL HERNIA REPAIR WITH A KUGEL MESH PATCH. ON (B)(6) 2007, EXPLORATORY LAPAROTOMY, EXPLANT OF KUGEL MESH, REPAIR OF RECURRENT RIGHT LOWER QUADRANT HERNIA WITH SUTURES. MESH NOTED TO HAVE CONTRACTED. ON (B)(6) 2007, REPAIR OF RECURRENT INCISIONAL HERNIA WITH COMPOSIX L/P MESH. ON (B)(6) 2008, OPEN VENTRAL HERNIA REPAIR WITH NON-BARD MESH. COMPOSIX L/P LEFT IN PLACE. ON (B)(6) 2008, VENTRAL HERNIA REPAIR WITH VENTRALEX MESH AND ABDOMINOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL PATCH FTL DAVOL INC NA 43EPD510

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention