BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTER-TIP I/A TIP WITH HANDLE

    MDR report key: 22009 · Received March 10, 1995

    Report

    Report Number
    1920664-1995-00092
    Event Type
    Other
    Date Received
    March 10, 1995
    Date of Event
    January 10, 1995
    Report Date
    January 31, 1995
    Manufacturer
    MICRO-SURGICAL TECHNOLOGY, INC.
    Product Code
    HKP
    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 HANDLESS AND 8 I/A TIPS WERE RETURNED FOR EVALUATION FROM THESE LOT NUMBERS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other