BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS MINIARC PRO SINGLE INCISION SLING SYSTEM

    MDR report key: 5396900 · Received January 28, 2016

    Report

    Report Number
    3011770902-2016-00051
    Event Type
    Injury
    Date Received
    January 28, 2016
    Date of Event
    January 19, 2016
    Report Date
    January 22, 2016
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    PAH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF A MINIARC PRO, THE PATIENT EXPERIENCED DIFFICULTY EMPTYING BLADDER. THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL WITH A FOLEY CATHETER FOR A POST-VOID RESIDUAL (PVR) OF 450CC. THE PATIENT HAD ANOTHER VOIDING TRIAL AND THE FOLEY CATHETER WAS BACKFILLED WITH 360CC STERILE WATER, THEN WAS REMOVED. THE PATIENT VOIDED 250CC. THE EVENT WAS CONSIDERED RECOVERED/RESOLVED WITH SEQUELAE ON (B)(6) 2016. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT. RELATED TO MFR # 3011770902-2016-00050.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55636 AMS MINIARC PRO SINGLE INCISION SLING SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, MINI-SLING PAH ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CYSTOSCOPIC BIOPSY