BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTER-TIP I/A TIP W/HANDLE

    MDR report key: 21984 · Received March 10, 1995

    Report

    Report Number
    1920664-1994-00091
    Event Type
    Other
    Date Received
    March 10, 1995
    Date of Event
    December 13, 1994
    Report Date
    January 31, 1995
    Manufacturer
    MICRO-SURGICAL TECHNOLOGY, INC.
    Product Code
    HQE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER SURGERY USING THIS DEVICE, THE PT SUFFERED ENDOPHTHALMITIS. THE CAUSE IS NOT KNOWN. WOULD LIKE THIS INSTRUMENT EVALUATED AS A POSSIBLE CAUSE FOR THIS CONDITION. THE PT IS RECOVERING.NOTE: 8 HANDLES (DP 9701) AND 8 I/A TIPS (DP9704) WERE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTER-TIP I/A TIP W/HANDLE IRRIGATION/ASPIRATION HANDPIECE HQE MICRO-SURGICAL TECHNOLOGY, INC. IH90303 W/IH90300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other