BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SLING

    MDR report key: 3964637 · Received July 29, 2014

    Report

    Report Number
    2183959-2014-00329
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 15, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER AND BRAND OF THE PELVIC MESH PRODUCT THAT WAS IMPLANTED IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN UNKNOWN SLING IMPLANTED ON AN UNKNOWN DATE. IT WAS INDICATED THAT THE LEVEL OF INCONTINENCE WAS WORSE AFTER THE UNKNOWN SLING WAS IMPLANTED. ON (B)(6) 2014 THE PATIENT WAS IMPLANTED WITH ANOTHER INCONTINENCE DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441835 UNKNOWN SLING UNKNOWN OTM AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R