BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS SPARC SLING SYSTEM

    MDR report key: 5385073 · Received January 22, 2016

    Report

    Report Number
    3011770902-2016-00046
    Event Type
    Malfunction
    Date Received
    January 22, 2016
    Date of Event
    January 20, 2016
    Report Date
    January 20, 2016
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SENT WITH THE ANALYSIS RESULTS WHEN COMPLETE.

    Additional Manufacturer Narrative · 1

    NO DAMAGE IS APPARENT ON SLING. UNABLE TO DETERMINE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT OF A SPARC SLING, THE SLING OVER-TIGHTENED UNDER THE URETHRA. THIS WAS UPON REMOVAL OF THE STICKY SHEATHS. AN ATTEMPT WAS MADE TO LOOSEN THE SLING WITH THE ADJUSTMENT SUTURE BUT IT THEN "DISTORTED" THE MESH. THE MESH THEN DID NOT HAVE THE APPROPRIATE WIDTH. THE PHYSICIAN DECIDED TO REMOVE THE MESH AND INSERT ANOTHER SLING. THE NEW SLING WAS IMPLANTED WITH NO ISSUES. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45208 AMS SPARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1