BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARDS

    MDR report key: 67891 · Received January 6, 1997

    Report

    Report Number
    67891
    Event Type
    Malfunction
    Date Received
    January 6, 1997
    Date of Event
    October 16, 1996
    Report Date
    October 23, 1996
    Manufacturer
    SMITH NEPHEW RICHARDS
    Product Code
    JYQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A STAPEDECTOMY CASE THE PHYSICIAN WAS GIVEN DEVICE. PHYSICIAN STATED THAT PROSTHESIS WAS DEFECTIVE BECAUSE THE HOOK WAS "TOO CLOSED" TO PROPERLY AFFIX TO THE MIDDLE EAR STRUCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RICHARDS HOUSE-TYPE WIRE LOOP JYQ SMITH NEPHEW RICHARDS * 4085175464

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other