BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 1973874 · Received January 19, 2011

    Report

    Report Number
    1213643-2011-00021
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    February 4, 2010
    Report Date
    December 30, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, 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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL RPTR TO REQUEST ADDITIONAL INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: ON (B)(6) 1999: TWO KUGEL HERNIA MESH PATCHES WERE USED TO REPAIR PT'S HERNIA DEFECT. ON (B)(6) 2010: PT PRESENTED TO THE HOSPITAL WITH INTENSE ABDOMINAL PAIN. HIS SURGEON DECIDED TO TAKE HIM INTO SURGERY ON THE SAME DAY WHERE HE FOUND A 2-3 MM DIAMETER FIBRIL OF PLASTIC MEASURING APPROXIMATELY 3 INCHES IN LENGTH THAT WAS REMOVED. HE ALSO NOTED THAT THE MESH HAD ALSO MOST LIKELY MIGRATED AND ERODED THROUGH THE INGUINAL WALL AND HAD ADHERED TO THE SIGMOID COLON CAUSING A PERFORATION. THE COLON AND PORTIONS OF THE BOWEL HAD TO BE RESECTED. ON (B)(6) 2010: PT PRESENTED TO THE ER WITH CONTINUED PAIN. IT WAS DETERMINED THAT PT HAD DEVELOPED AN ABSCESS AND INFECTION, WHICH REQUIRED ADDITIONAL SURGERY TO REPAIR. ON (B)(6) 2010: PT WAS REVIEWED AT THE HOSPITAL AND DETERMINED TO HAVE A FISTULA ADJACENT TO THE SMALL BOWEL. THIS REQUIRED ANOTHER ADDITIONAL SURGERY. PT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL PATCH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 121198

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention