BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0113022

    MDR report key: 38834 · Received August 30, 1996

    Report

    Report Number
    2018492-1996-00001
    Event Type
    Malfunction
    Date Received
    August 30, 1996
    Date of Event
    August 2, 1996
    Report Date
    August 2, 1996
    Manufacturer
    BURTON MEDICAL PRODUCTS
    Product Code
    FQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INJURY SO THERE ARE NO PT CODES THAT ARE APPLICABLE TO THIS REPORT.

    Description of Event or Problem · 1

    THE REFLECTOR HEAD FELL DURING USE IN A PROCEDURE NARROWLY MISSING THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0113022 NA FQP BURTON MEDICAL PRODUCTS 0113022 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA