BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-CHECKS STEAM INTEGRATOR

    MDR report key: 16453995 · Received February 27, 2023

    Report

    Report Number
    MW5115283
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    February 22, 2023
    Report Date
    February 23, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    JOJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MED-CHECKS STEAM INTEGRATOR BY MEDLINE. OBSERVED HAIR EMBEDDED IN LAMINATE ON BACK OF INTEGRATOR. LOT#221001. OBSERVED DELAMINATION ON INTEGRATOR. LOT #221001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946884 MED-CHECKS STEAM INTEGRATOR INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS JOJ MEDLINE INDUSTRIES, LP - NORTHFIELD MDS200600 221001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown