BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ADVANCE MALE SLING SYSTEM

    MDR report key: 4112560 · Received September 24, 2014

    Report

    Report Number
    2183959-2014-00418
    Event Type
    Injury
    Date Received
    September 24, 2014
    Report Date
    August 25, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: WHICH WAS PREVIOUSLY REPORTED AS (B)(6) 2014 AND SHOULD HAVE BEEN (B)(6) 2014. CORRECTION: BRAND NAME PREVIOUSLY REPORTED AS "UNKNOWN SLING" CORRECTED TO "AMS ADVANCE MALE SLING SYSTEM." CORRECTION : COMMON DEVICE NAME PREVIOUSLY REPORTED AS "UNKNOWN" CORRECTED TO "SURGICAL MESH." CORRECTION: PROCODE PREVIOUSLY REPORTED AS "NA" CORRECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ADVANCE SLING IMPLANTED. FOLLOWING THE IMPLANT THE PATIENT HAD INCONTINENCE THAT WAS WORSE THAN BASELINE. SURGERY WAS PERFORMED AND AN AMS800 ARTIFICIAL URINARY SPHINCTER CONTINENCE WAS IMPLANTED ON (B)(6) 2014. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593509 AMS ADVANCE MALE SLING SYSTEM SURGICAL MESH OTM AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R