BEUDAMED
    FDA Adverse Event Other Summary report: N

    MED-TEC UNI-FRAME

    MDR report key: 313833 · Received January 24, 2001

    Report

    Report Number
    1932738-2001-00001
    Event Type
    Other
    Date Received
    January 24, 2001
    Date of Event
    January 14, 2001
    Report Date
    January 23, 2001
    Manufacturer
    MED-TEC,INC.
    Product Code
    IWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PT WAS TREATED WITH SHELL LAST DECEMBER AND CLAIMED ALLERGY TO DEVICE. RASH APPEARED BETWEEN LIP AND JAW ORIGINALLY AND THEN APPEARED ON WHOLE BODY. MED-TEC'S UNI-FRAME SHELL WAS USED AND THE PT HAD A SIMILAR REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3003 MED-TEC UNI-FRAME RADIOGRAPHIC HEAD HOLDER IWY MED-TEC,INC. MT-APU-14 19082

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other