BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS RETROARC RETROPUBIC SLING SYSTEM

    MDR report key: 3630052 · Received February 15, 2014

    Report

    Report Number
    2183959-2014-00033
    Event Type
    Injury
    Date Received
    February 15, 2014
    Date of Event
    December 11, 2013
    Report Date
    December 16, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH AN AMS RETROARC SLING DEVICE AS PART OF A VAGINAL POP (PELVIC ORGAN PROLAPSE) SURGERY THAT OCCURRED ON (B)(6) 2013. A HYSTERECTOMY & COLPORRHAPHIES WERE PERFORMED UNDER GENERAL ANAESTHESIA. THE RETROARC PROCEDURE WAS REPORTED TO HAVE TAKEN 16 MINUTES, THE CYSTOSCOPY WAS "OK." IT WAS INDICATED THAT THE "SLIDING OF THE VINIL-COVERED TAPE THROUGH THE TISSUE WAS NOT SMOOTH. DIFFICULT PASSING THROUGH THE RETROPUBIC SPACE, HIGH NEEDLE PULL-OUT POWER REQUIRED." NO PATIENT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2014 THAT REPORTED ALL THREE PATIENTS ARE FINE. "THEY ARE SATISFIED WITH THE PROCEDURE. THEY ARE COMPLETELY DRY, ONE OF THEM EXPERIENCES SOME OAB (OVERACTIVE BLADDER) SYMPTOMS WHICH ARE WELL CONTROLLED WITH SOLIFENACIN." WHICH PATIENT EXPERIENCED THE OAB SYMPTOMS WAS NOT PROVIDED. NO FURTHER COMPLICATIONS WERE REPORTED IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99690 AMS RETROARC RETROPUBIC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention