BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 3021641 · Received March 15, 2013

    Report

    Report Number
    1213643-2013-00103
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    April 26, 2007
    Report Date
    March 1, 2013
    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
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE, HOWEVER, CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO AND IF AVAILABLE, TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THE ATTORNEY'S REPORT ALLEGES THAT THE PT WAS TREATED FOR ADHESIONS, WHICH IS A KNOWN POSSIBLE ADVERSE REACTION LISTED IN THE IFU. A MFG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS REC'D TO DATE. IF ADD'L EVENT AND/OR EVALUATION INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. SEE MDR 1213643-2013-00102 FOR INFO RELATED OT THE OTHER BARD KUGEL PATCH IMPLANTED ON (B)(6) 2004.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY: ON (B)(6) 2004 TWO BARD KUGEL PATCHES WERE USED TO REPAIR THE PT'S HERNIA DEFECT. ON (B)(6) 2007 THE PT PRESENTED TO THE HOSPITAL FOR SURGERY TO EXPLANT THE MESH. DURING SURGERY, THE PT'S SURGEON NOTED THAT, "THE LEFT SIDE DID SHOW THE MESH TO BE SLIGHTLY PROTRUDING LATERALLY" AND THAT SUBSEQUENT TO SUBSTANTIAL ADHESIONS OF THE MESH TO THE CORD STRUCTURES, THE "MESH COULD NOT BE REMOVED IN ONE PIECE." ON 2007 FOLLOWING SURGERY TO EXPLANT THE MESH THE PT WAS FOUND TO BE SUFFERING FROM SEVERE TESTICULAR PAIN. ON (B)(6) 2007 THE PT UNDERWENT A LEFT INGUINAL ORCHIECTOMY TO REMOVE HIS LEFT TESTICLE. THE ATTORNEY FOR THE PT ALLEGES PERMANENT INJURY, PAIN, ADD'L SURGERY, ADHESIONS, DEFECTIVE MESH, EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110616 KUGEL PATCH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43JND507

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability