BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN WOMEN'S HEALTH PRODUCT

    MDR report key: 2903480 · Received January 3, 2013

    Report

    Report Number
    1018233-2012-02206
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 4, 2012
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    FTL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT FAMILY FOR THIS WOMEN'S HEALTH PRODUCT IS UNK; AND THEREFORE, THE APPROPRIATE LABELING/PRODUCT DOCUMENTS FOR REVIEW COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PT REPORTED THAT AS A RESULT OF HAVING A BARD WOMEN'S MESH PRODUCT IMPLANTED, SHE WAS EXPERIENCED PELVIC PAIN, SCARRING, BLEEDING AND DYSPAREUNIA. PER ADDITIONAL INFO RECEIVED, THE BARD DEVICE WAS IMPLANTED IN 1998. THE PT CONTINUES TO EXPERIENCE BLADDER LEAKAGE DYSPAREUNIA, INCONTINENCE AND HAS DEVELOPED INTERSTITIAL CYSTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3464 UNKNOWN WOMEN'S HEALTH PRODUCT FTL C.R. BARD, INC. (COVINGTON) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention