BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 2032723 · Received March 17, 2011

    Report

    Report Number
    1213643-2011-00089
    Event Type
    Injury
    Date Received
    March 17, 2011
    Report Date
    February 25, 2011
    Manufacturer
    DAVOL INC, SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K002684
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT BASED ON THE INFORMATION CURRENTLY AVAILABLE. FURTHERMORE, NO PRODUCT HAS BEEN RETURNED NOR HAS A SPECIFIC PRODUCT PROBLEM BEEN REPORTED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE MANUFACTURER OF THE CALDERA MEDICAL T-SLING HAS BEEN NOTIFIED OF THE EVENT.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: ON (B)(6) 2005: PT WAS IMPLANTED WITH A BARD COMPOSIX EX MESH AND A CALDERA MEDICAL T-SLING FOR TREATMENT OF STRUCTURAL WEAKNESS RESULTING IN STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. AS A RESULT OF IMPLANTATION, THE PT SUFFERED SERIOUS BODILY INJURIES, INCLUDING EXTREME PAIN, EROSION OF HER INTERNAL BODILY TISSUES AND OTHER INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX MESH E/X FTL DAVOL INC, SUB. C.R. BARD, INC. NA 43APD458

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention