BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 3964226 · Received July 11, 2014

    Report

    Report Number
    1213643-2014-00219
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    April 4, 2014
    Report Date
    June 16, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S ATTY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PATIENT INJURY AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THAT PATIENT'S ATTY: ON (B)(6) 2003 THE PATIENT WAS IMPLANTED WITH A BARD KUGEL MESH. ON (B)(6) 2014 THE PATIENT UNDERWENT ALLEGED EXPLANT OF THE BARD KUGEL MESH. THE ATTY'S REPORT ALLEGES PAIN, INJURY, ADDITIONAL MEDICAL TREATMENT, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407580 KUGEL PATCH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43HND281

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S