BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYSTOSCOPE

    MDR report key: 5161820 · Received October 14, 2015

    Report

    Report Number
    MW5057216
    Event Type
    Injury
    Date Received
    October 14, 2015
    Date of Event
    September 18, 2015
    Report Date
    October 14, 2015
    Manufacturer
    ACMI
    Product Code
    FAJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED MEDICAL PROCEDURE THAT INVOLVED A RIGID SCOPE TO LOOK AT MY BLADDER. I ACQUIRED AN INFECTION AFTER THE PROCEDURE. I SPOKE TO AN ACQUAINTANCE AND THE TOPIC OF THIRD PARTY REPAIR CAME UP AND THE FACT THAT NO COMPANY WILL VALIDATE STERILITY OF ANY ITEM THAT IS REPAIRED BY A THIRD PARTY COMPANY ONLY STANDING BEHIND AND VALIDATING STERILITY FROM THE OEM. ARE THESE REPAIR COMPANIES REGULATED BY THE FDA AND IF NOT WHY ARE THEY ALLOWED TO REPAIR MEDICAL DEVICES AND THEN BE USED IN MEDICAL PROCEDURES WITHOUT BEING VALIDATED FOR STERILITY? WHY AS A PATIENT ISN'T ANY HEALTHCARE PROVIDER NOTIFYING ME THAT THEY WERE USING SUCH INSTRUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678313 CYSTOSCOPE CYSTOSCOPE FAJ ACMI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other