BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECHFORM PREMIUM CAST TAPE

    MDR report key: 3597228 · Received January 14, 2014

    Report

    Report Number
    2085446-2014-00001
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    November 26, 2013
    Report Date
    January 14, 2014
    Manufacturer
    BL TECH CO LTD.
    Product Code
    ITG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS PROVIDED WITH A TOPICAL STEROID. WE PROVIDED A COPY OF THE MSDS TO THE PRACTITIONER.

    Description of Event or Problem · 1

    WHILE TECHNICIAN CUT CAST OFF PATIENT, THE CAST REMOVAL CREATED DUST. THE PATIENT INHALED THE DUST AND DEVELOPED SKIN RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36558 TECHFORM PREMIUM CAST TAPE BANDAGE, CAST ITG BL TECH CO LTD. 204WH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention