BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SLING

    MDR report key: 3800184 · Received May 8, 2014

    Report

    Report Number
    2183959-2014-00150
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 9, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FTL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN UNKNOWN "MID URETHRAL TAPE FOR INCONTINENCE" IMPLANTED ON AN UNSPECIFIED DATE. THE PATIENT EXPERIENCED "OBSTRUCTED VOIDING" AND "DIVISION OF TAPE -CONTINUING INCONTINENCE REQUIRING FURTHER SURGERY." THE DETAILS OF THE ADDITIONAL SURGERY WERE NOT PROVIDED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278470 UNKNOWN SLING UNKNOWN FTL AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R