BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ADVANCE MALE SLING SYSTEM

    MDR report key: 3911487 · Received July 3, 2014

    Report

    Report Number
    2183959-2014-00271
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT HE HAD AN ADVANCE SLING IMPLANTED APPROXIMATELY 8 YEARS AGO. INITIALLY IT SIGNIFICANTLY REDUCED THE INCONTINENCE GOING FROM OVER 3 PADS DOWN TO LESS THAN 1. HIS CONDITION IS CONTINUING TO DETERIORATE AND HE IS NOW BETWEEN 1.5 TO 2 PADS PER DAY. THE PATIENT ALSO REPORTS THAT HE HAS NOTICED A DETERIORATION IN BLADDER CONTROL. WHEN THE URGE TO URINATE DEVELOPS, HIS ABILITY TO CONTROL THE URGE UNTIL HE IS ABLE TO URINATE IS BECOMING "LESS AND LESS." A PHYSICIAN RECOMMENDED HE START TAKING MEDICATION HOWEVER, HE HAS NOT TAKEN THAT ADVICE AND CONTACTED HIS UROLOGIST TO INQUIRE ABOUT AVAILABLE OPTIONS. NO REVISION SURGERY SCHEDULED AT THIS TIME AND THE PATIENT OUTCOME WAS REPORTED AS "INCONTINENCE." NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390240 AMS ADVANCE MALE SLING SYSTEM SURGICAL MESH OTM AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability