BEUDAMED
    FDA Adverse Event Other Summary report: N

    MILTEX

    MDR report key: 129273 · Received October 27, 1997

    Report

    Report Number
    2431021-1997-00012
    Event Type
    Other
    Date Received
    October 27, 1997
    Date of Event
    January 31, 1997
    Report Date
    October 16, 1997
    Manufacturer
    MILTEX INSTRUMENT CO.
    Product Code
    EAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT SWALLOWED MIRROR/HOUSING WHEN IT BROKE AWAY FROM SPOT WELD AT STEM. BOTH PT AND DENTIST WERE UNAWARE THAT THE MIRROR WAS SWALLOWED UNTIL X-RAYS WERE TAKEN. PT PASSED THE MIRROR/HOUSING ON THE FOLLOWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILTEX #5-MOUTH MIRROR, FRONT SURFACE EAX MILTEX INSTRUMENT CO. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention