BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS MONARC+ SUBFASCIAL HAMMOCK

    MDR report key: 4200611 · Received October 24, 2014

    Report

    Report Number
    2183959-2014-50971
    Event Type
    Injury
    Date Received
    October 24, 2014
    Report Date
    July 3, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TOTAL NUMBER OF EVENTS SUMMARIZED - (B)(4). AMS APOGEE PC WITH INTEXEN LP - (B)(4). AMS APOGEE SYSTEM - (B)(4). AMS BIO ARC PRE-CONNECTED COLLAGEN DERMAL - (B)(4). AMS BIO ARC SLING SYSTEM - (B)(4). AMS ELEVATE (NOT SPECIFIED) - (B)(4). AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE - (B)(4). AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE - (B)(4). AMS INTEXEN-PORCINE DERMIS - (B)(4). AMS MINIARC SLING SYSTEM - (B)(4). AMS MONARC C-SLING SYSTEM - (B)(4). AMS MONARC SLING SYSTEM - (B)(4). AMS MONARC+ SUBFASCIAL HAMMOCK - (B)(4). AMS PERIGEE SYSTEM - (B)(4). AMS SPARC SLING SYSTEM - (B)(4). INFAST SLING - (B)(4). UNKNOWN GRAFT MESH - (B)(4). UNKNOWN SLING SYSTEM - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED AN UNSPECIFIED INJURY. THE DEVICE REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678668 AMS MONARC+ SUBFASCIAL HAMMOCK MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS 72404193

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability INTEXEN| INTEXEN