BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLCARE

    MDR report key: 19729348 · Received July 12, 2024

    Report

    Report Number
    19729348
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 24, 2024
    Manufacturer
    ALLCARE, INC
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHEN OPENING TWO PACKAGES OF TOWELS, IT WAS NOTED THAT THE PACKAGE TORE EASILY CAUSING THE TOWELS TO BE CONTAMINATED BOTH TIMES. THIS WAS CAUGHT BEFORE PLACING THEM ON THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289733 ALLCARE FIBER, MEDICAL, ABSORBENT FRL ALLCARE, INC ORB-06 11WK26

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown