BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGHT ANGLE PICK

    MDR report key: 34730 · Received June 29, 1996

    Report

    Report Number
    34730
    Event Type
    Malfunction
    Date Received
    June 29, 1996
    Date of Event
    June 18, 1996
    Report Date
    June 24, 1996
    Manufacturer
    V. MUELLER DIV. BAXTER HEALTHCARE CORP.
    Product Code
    JYT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE INSTRUMENT BROKE OFF IN THE INNER EAR DURING SURGERY. THE BROKEN PIECE COULD NOT BE RETRIEVED FROM THE EAR. THE INCIDENT DID NOT CAUSE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR STRUCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGHT ANGLE PICK RIGHT ANGLE PICK JYT V. MUELLER DIV. BAXTER HEALTHCARE CORP. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR