BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESCULAP JS CONTAINER

    MDR report key: 11921821 · Received June 1, 2021

    Report

    Report Number
    MW5101653
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    November 16, 2021
    Report Date
    May 27, 2021
    Manufacturer
    AESCULAP, INC.
    Product Code
    KCT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AESCULAP JS SERIES CONTAINERS DEVELOP A LAYER OF ALUMINUM HYDROXIDE ON THEM AFTER CONTINUED USE IN THE STERRAD. THE POWDER BUILDS UP TO THE POINT OF IT FALLING ONTO STERILE INSTRUMENTS INSIDE THE CONTAINER. THIS IS HAPPENING IN SEVERAL FACILITIES THROUGHOUT THE COUNTRY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807573 AESCULAP JS CONTAINER STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES KCT AESCULAP, INC. JS440

    Patients

    Seq Age Sex Outcome Treatment
    1