BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUFFLITE LIDS

    MDR report key: 55775 · Received December 9, 1996

    Report

    Report Number
    2916714-1996-00010
    Event Type
    Injury
    Date Received
    December 9, 1996
    Date of Event
    November 1, 1996
    Report Date
    December 9, 1996
    Manufacturer
    AESCULAP
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A CENTRAL PROCESSING NURSE MANAGER REPORTED THAT A 34 YO FEMALE NURSE DEVELOPED WRIST AND THUMB STRAIN/DISCOMFORT WHILE REMOVING LIDS FROM STERILE CONTAINER SYSTEM. THE NURSE WAS DIAGNOSED WITH TRIGGER FINGER AND TREATED WITH CORTISONE INJECTIONS. SHE WAS ABLE TO RETURN TO WORK WITH MODIFIED DUTY. AN ORTHOPEDIC SURGEON IS FOLLOWING THE CASE TO DETERMINE IF SURGERY WILL BE REQUIRED IN THE FUTURE. THE HOSP STAFF WAS USING A NON-STANDARD METHOD FOR RELEASING THE LATCHES ON THE LIDS. THEY HAVE SWITCHED TO USING AN ARMY-NAVY RETRACTOR DEVICE TO OPEN THE LIDS. THIS ADVERSE EVENT IS OCCURRING AT OR BELOW THE FREQUENCY OR SEVERITY THAT ARE USUAL FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUFFLITE LIDS STERILIZATION CONTAINER LID FLE AESCULAP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention