BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ADVANCE MALE SLING SYSTEM

    MDR report key: 3962858 · Received July 29, 2014

    Report

    Report Number
    2183959-2014-00325
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 14, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING RECURRING INCONTINENCE, AND THE PHYSICIAN THOUGHT THE SLING "NEED[ED] TO BE TIGHTENED". DURING SURGERY, THE PATIENT HAD HIS ADVANCE REMOVED AND A NEW ONE PLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442225 AMS ADVANCE MALE SLING SYSTEM SURGICAL MESH OTM AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R