BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 2171350 · Received July 18, 2011

    Report

    Report Number
    1213643-2011-00342
    Event Type
    Injury
    Date Received
    July 18, 2011
    Report Date
    June 23, 2011
    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
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATIVE REPORT PROVIDED INDICATES THE PATIENT WAS TREATED FOR A RECURRENT RIGHT INGUINAL HERNIA. THE OPERATIVE REPORT DID NOT INCLUDE A STATEMENT OR INDICATION THAT THERE WAS A POSSIBLE OR SUSPECT DEVICE FAILURE RELATED TO THE BARD MESH. NO SAMPLE WAS RETURNED FOR EVALUATION; HOWEVER, BASED ON THE CURRENTLY AVAILABLE INFORMATION NO BARD MESH DEVICE FAILURE OCCURRED. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVALUATION OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PER PATIENT: ON (B)(6) 2008 - THE PATIENT REPORTED HE UNDERWENT KUGEL MESH IMPLANT. PATIENT REPORTED HE HAS UNDERGONE PAIN MEDICATION THERAPY FOR CONSTANT PAIN AND IS DISABLED. PER PROVIDED MEDICAL RECORDS: ON (B)(6) 2008: REPAIR OF A RECURRENT RIGHT INGUINAL HERNIA. REMOVAL OF OLD (UNIDENTIFIED) MESH. DURING THE PROCEDURE A KUGEL HERNIA PATCH WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL PATCH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HURF1535

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability PAIN MANAGEMENT-PRESCRIPTION PAIN MEDICATIONS