BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3182206 · Received June 14, 2013

    Report

    Report Number
    2183959-2013-00880
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 23, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD TWO SLINGS IMPLANTED. DATE OF THE SLING IMPLANT (S) WAS NOT PROVIDED. IT WAS REPORTED THAT THE PT EXPERIENCED "EROSION" ON ONE OF THE SLINGS. AN ALTERNATIVE INCONTINENCE DEVICE WAS IMPLANTED ON (B)(6) 2013. NO ADD'L PT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272125 UNK SURGICAL SLING OTM AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R