BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL CONTACT CAST

    MDR report key: 9835079 · Received March 16, 2020

    Report

    Report Number
    9835079
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 6, 2020
    Report Date
    February 25, 2020
    Manufacturer
    BSN MEDICAL, INC.
    Product Code
    ITG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    TWO EVENTS WITH SAME ISSUE: MINOR INJURY DURING CAST REMOVAL WITH USE OF CAST SAW. TWO SEPARATE USERS REPORTED BLADE SLIPPED WHEN COMING IN CONTACT WITH NARROW REMOVAL GUIDE/PROTECTOR AND CAME IN CONTACT WITH THE SKIN DURING REMOVAL, CAUSING INJURY. USERS REPORT DIFFICULTY WITH USE DUE TO THE NARROW GUIDES/PROTECTORS.

    Description of Event or Problem · 1

    TWO EVENTS WITH SAME ISSUE: MINOR INJURY DURING CAST REMOVAL WITH USE OF CAST SAW. TWO SEPARATE USERS REPORTED BLADE SLIPPED WHEN COMING IN CONTACT WITH NARROW REMOVAL GUIDE/PROTECTOR AND CAME IN CONTACT WITH THE SKIN DURING REMOVAL, CAUSING INJURY. USERS REPORT DIFFICULTY WITH USE DUE TO THE NARROW GUIDES/PROTECTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299382 TOTAL CONTACT CAST INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL ITG BSN MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other