BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SLING

    MDR report key: 4922382 · Received July 17, 2015

    Report

    Report Number
    2183959-2015-00321
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    April 3, 2012
    Report Date
    July 7, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN UNKNOWN SLING, THE PATIENT EXPERIENCED "EXCRUCIATING PAIN, MOBILITY ISSUES, STILL LEAKING MORE THAN WHAT I WAS, PIN/NEEDLES NUMBNESS ON RIGHT LEG, GROIN PAIN". THE PATIENT ALSO ALLEGED THAT SHE EXPERIENCED "MIGRAINES", "MORE INCONTINENCE THAN I HAD CUT TO, MY L[A]BIA...HAD TO RETURN TO HAVE STITCHES 3 DAYS LATER NOW HAVING BOWEL PROBLEMS", "HIP/BACK ARM ELBOW EFFECTED TOO", "ANXIETY, PANIC ATTACKS" AND "DEPRESSION". THE MESH WAS REMOVED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465269 UNKNOWN SLING UNKNOWN OTN AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R