BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ADVANCE MALE SLING SYSTEM

    MDR report key: 3932690 · Received July 14, 2014

    Report

    Report Number
    2183959-2014-00299
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    May 16, 2013
    Report Date
    June 18, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLARIFICATION: MW5057580 INDICATED THE IMPLANT DATE WAS (B)(6) 2013; HOWEVER THE PHYSICIAN PROVIDED THE IMPLANT DATE AS (B)(6) 2013 AS REPORTED ON THE INITIAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH AN ADVANCE URINARY INCONTINENCE SLING DEVICE ON (B)(6) 2013. AFTER IMPLANTATION THE INCONTINENCE STATUS OF THE PATIENT WAS REPORTEDLY WORSE. SUBSEQUENTLY ON (B)(6) 2014 PATIENT WAS IMPLANTED WITH AN ALTERNATIVE CONTINENCE DEVICE, OUTCOME WAS REPORTEDLY "PENDING." NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT EXPERIENCED "PAIN, HEAVINESS IN THE BLADDER, URINARY RETENTION AND INCONTINENCE." THE PATIENT STATED THAT THE "MESH BROKE" AND "ERODED IN THE BODY". THE MESH WAS EXPLANTED AND THE PATIENT CONTINUED TO EXPERIENCE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409366 AMS ADVANCE MALE SLING SYSTEM SURGICAL MESH OTM AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R