BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 8546955 · Received April 24, 2019

    Report

    Report Number
    2183959-2019-62532
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    March 29, 2019
    Report Date
    June 19, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953000725
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS: ANALYSIS OF THE BELT CUFF FGS 4.5 CM REVEALED A LEAK AT THE SHELL ADAPTER JUNCTION WITH WEAR ON THE FOLD. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, THE MOST PROBABLE CAUSE FOR THIS COMPLAINT WAS CONSIDERED CAUSE TRACED TO COMPONENT FAILURE. THIS COMPLAINT INVESTIGATION CONCLUSION CODE IS UTILIZED FOR AN EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. BASED ON THE RESULTS OF THIS INVESTIGATION, NO ESCALATION IS NECESSARY. ADDITIONAL PRODUCT COMPONENT: MODEL NUMBER/CATALOG NUMBER: 7240002, SERIAL NUMBER: NULL, MODEL/CATALOG DESCRIPTION: BALLOON FGS 71-80CM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING INCONTINENCE DUE TO THE CUFF HAVING A SMALL HOLE RESULTING IN FLUID LOSS WITH AN ARTIFICIAL URINARY SPHINCTER (AUS). THE AUS CUFF AND BALLOON WERE EXPLANTED AND A NEW AUS CUFF AND BALLOON WERE IMPLANTED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE OR THE PRODUCT WAS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT ANALYSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT COMPONENT: MODEL NUMBER/CATALOG NUMBER- 72400025, SERIAL NUMBER: NULL, MODEL/CATALOG DESCRIPTION- BALLOON FGS 71-80CM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING INCONTINENCE DUE TO THE CUFF HAVING A SMALL HOLE RESULTING IN FLUID LOSS WITH AN ARTIFICIAL URINARY SPHINCTER (AUS). THE AUS CUFF AND BALLOON WERE EXPLANTED AND A NEW AUS CUFF AND BALLOON WERE IMPLANTED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE OR THE PRODUCT WAS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338813 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72400161 945294013 00878953000725

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R