BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIARC SINGLE-INCISION SLING

    MDR report key: 2770345 · Received October 1, 2012

    Report

    Report Number
    2183959-2012-02830
    Event Type
    Injury
    Date Received
    October 1, 2012
    Report Date
    September 6, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IN 2010, A MINIARC WAS IMPLANTED. DURING THE SAME SURGERY A HYSTERECTOMY WAS PERFORMED. IT WAS REPORTED THAT WHILE DOING LEG EXERCISES AFTER KNEE SURGERY, SHE FELT A PULL AND HAS HAD PAIN AND CONTINUOUS LEAKAGE EVER SINCE. IN (B)(6) 2011 SHE SAW HER UROLOGIST WHO DECIDED HE WOULD NOT REMOVE THE DEVICE BECAUSE SHE WAS DOING "OK" AND SHE WAS PRESCRIBED MEDICATION. THE PT DID NOT CONTINUE HER MEDICATION AND HAS NOT RETURNED TO HER DOCTOR SINCE THEN. THE PT WAS CONCERNED THAT SHE HAD A FAULTY PRODUCT AND PLANNED TO CONTACT THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIARC SINGLE-INCISION SLING SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S BOSTON SCIENTIFIC MESH GRAFT