BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING SYSTEM

    MDR report key: 1841194 · Received September 16, 2010

    Report

    Report Number
    2183959-2010-00346
    Event Type
    Injury
    Date Received
    September 16, 2010
    Report Date
    September 10, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT REPORTED BY PT VIA MEDWATCH. PHYSICIAN OR PHYSICIAN NAMES WERE NOT PROVIDED. UNABLE TO FOLLOW-UP. NO DEVICE MALFUNCTION WAS REPORTED. DEVICE WAS NOT EXPLANTED. SERIAL NUMBER NOT PROVIDED FOR HISTORY REVIEW. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    INFO RECEIVED STATES: "PT IS EXPERIENCING SMELLY URINE, FATIGUE, LETHARGY, WEAKNESS, TROUBLE SLEEPING, WALKING DIFFICULTIES AND RECURRENT, UNRESOLVED E COLI INFECTIONS. PT HAS TAKEN MANY ABT REGIMENS IN 6 MOS AND IS CURRENTLY ON LOW DOSE DAILY ABT." NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARC SLING SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability