BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 8035721 · Received November 2, 2018

    Report

    Report Number
    2183959-2018-60634
    Event Type
    Injury
    Date Received
    November 2, 2018
    Date of Event
    July 3, 2018
    Report Date
    May 30, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CATALOG #: BALLOON: UNKNOWN. CUFF: 72400163. EXPIRATION DATE: BALLOON: UNKNOWN. CUFF: 09/09/2013. SERIAL #: BALLOON: UNKNOWN. CUFF: (B)(4). UDI #: BALLOON: UNKNOWN. CUFF: (B)(4). DEVICE MANUFACTURE DATE: BALLOON: UNKNOWN. CUFF: 09/2008. THE COMPLAINT COMPONENT WAS RETURNED AND ANALYZED, AND THE REPORTED ALLEGATION WAS CONFIRMED VIA PRODUCT ANALYSIS. THE EVENT CANNOT BE REPRODUCED OR SUBSTANTIATED; THEREFORE, NO ESCALATION TO NCEP, CAPA OR SCAR IS REQUIRED. CORRECTION UPDATED TO INCLUDE DEVICE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARTIFICIAL URINARY SPHINCTER (AUS) CUFF AND BALLOON WERE REMOVED ON (B)(6) 2018 DUE TO A "PIERCED BALLOON". IT IS UNCLEAR IF A NEW DEVICE WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    CATALOG #: BALLOON: UNKNOWN CUFF: 72400163; EXPIRATION DATE: BALLOON: UNKNOWN CUFF: 09/09/2013; SERIAL #: BALLOON: UNKNOWN CUFF: (B)(4); UDI #: BALLOON: UNKNOWN CUFF: (B)(4); DEVICE MANUFACTURE DATE: BALLOON: UNKNOWN, CUFF: 09/2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARTIFICIAL URINARY SPHINCTER (AUS) CUFF AND BALLOON WERE REMOVED ON (B)(6) 2018 DUE TO A "PIERCED BALLOON". IT IS UNCLEAR IF A NEW DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872719 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION UNK-P-AUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R