BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BMD WOMEN'S HEALTH PRODUCT

    MDR report key: 3252126 · Received July 25, 2013

    Report

    Report Number
    1018233-2013-02980
    Event Type
    Injury
    Date Received
    July 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    FTM
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT FAMILY FOR THIS WOMEN'S HEALTHCARE PRODUCT IS UNKNOWN. THEREFORE WE ARE UNABLE TO DETERMINE THE ASSOCIATED LABELING AND (B)(4) TO REVIEW. ALTHOUGH THE PRODUCT FAMILY IS UNKNOWN, THE WOMEN HEALTH PRODUCT IFUS ARE FOUND TO BE ADEQUATE BASED ON PAST REVIEWS.

    Description of Event or Problem · 1

    COMPLAINT NUMBER (B)(4). IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INJURIES, PAIN, DISABILITY, AND IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347410 UNKNOWN BMD WOMEN'S HEALTH PRODUCT UNK FTM C.R. BARD, INC. (COVINGTON) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention