BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ADVANCE MALE SLING SYSTEM

    MDR report key: 4182079 · Received October 17, 2014

    Report

    Report Number
    2183959-2014-00459
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    May 9, 2011
    Report Date
    October 6, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH AN ADVANCE URINARY INCONTINENCE SLING DEVICE ON (B)(6) 2011. AFTER IMPLANTATION THE PATIENT WAS REPORTED TO HAVE URINARY RETENTION. THE PATIENT HAD A CATHETER PLACED AND SUBSEQUENTLY UNDERWENT AN INCISION OF THE SLING TO RESOLVE. IT IS UNKNOWN WHETHER THE DEVICE WAS EXPLANTED. SUBSEQUENTLY ON (B)(6) 2014 PATIENT WAS IMPLANTED WITH AN ALTERNATIVE CONTINENCE DEVICE, OUTCOME WAS "UNKNOWN". NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660749 AMS ADVANCE MALE SLING SYSTEM SURGICAL MESH OTM AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R