BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENDTEC

    MDR report key: 107761 · Received June 30, 1997

    Report

    Report Number
    107761
    Event Type
    Malfunction
    Date Received
    June 30, 1997
    Date of Event
    December 27, 1996
    Report Date
    January 2, 1997
    Manufacturer
    MENDTEC
    Product Code
    EYD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOSPITAL SUBMITS THE FOLLOWING PURSUANT TO 21CFR803. IT IS BASED ON INFO REVIEWED BY HARTFORD HOSP WHICH IT MAY NOT HAVE HAD AN OPPORTUNITY TO INVESTIGATE FULLY OR VERIFY PRIOR TO THE REPORTING DATE. THIS REPORT SHALL NOT BE CONSTRUED AS AN ADMISSION BY HARTFORD HOSPITAL THAT IT OR ANY OF ITS EMPLOYEES OR AFFILIATES CAUSED OR CONTRIBUTED TO THE INCIDENT DESCRIBED HEREIN. WHILE THE PT WAS POSITIONED IN THE NEW ALLYN STIRRUPS FOR A LAP. SPLEEN PROCEDURE IN THE OR THE LEFT STIRRUPS GAVE WAY DURING THE PROCEDURE. THE LEFT LEG INTERNALLY ROTATED ABOUT 45 DEGREES THE PT SUSTAINED NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENDTEC ALLYN STIRRUP EYD MENDTEC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other