BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM W/INHIBIZONE

    MDR report key: 8103568 · Received November 26, 2018

    Report

    Report Number
    2183959-2018-00136
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    April 4, 2018
    Report Date
    September 6, 2018
    Manufacturer
    BOSTON SCIENTIFIC - MINNETONKA
    Product Code
    EZY
    UDI-DI
    00878953003092
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS: CUFF: 72404131, BALLOON: 72400024, PUMP: 72404127. (B)(4). EXPIRATION DATES: CUFF: 08/06/2015, BALLOON: 07/28/2019, PUMP: 09/03/2015. MANUFACTURE DATES: CUFF: 08/2014, BALLOON: 08/2014, PUMP: 09/2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S ARTIFICIAL URINARY SPHINCTER WAS REPLACED DUE TO ATROPHY. THIS COMPLAINT WAS INITIALLY SUBMITTED TO FDA VIA ASR REPORT Q3 2018 AND ADDITIONAL INFORMATION WAS RECEIVED BY BOSTON SCIENTIFIC. DUE TO THE REMOVAL OF EXEMPTION E1997037, THIS INFORMATION IS PROVIDED VIA SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940955 AMS 800 URINARY CONTROL SYSTEM W/INHIBIZONE DEVICE, INCONTINENCE, MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC - MINNETONKA 00878953003092

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R