BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 12737125 · Received November 2, 2021

    Report

    Report Number
    12737125
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    September 22, 2021
    Report Date
    September 30, 2021
    Manufacturer
    STERIS CORPORATION
    Product Code
    FTA
    UDI-DI
    00724995150136
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING SETUP OF CASE, HAIR FOUND INSIDE LIGHT HANDLE COVER PACKAGE THAT WAS INSIDE OF THE PACK. LIGHT HANDLE WAS PASSED OFF. SETUP CONTINUED. LOT# 7822210. PRODUCT AND PACKAGING SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637003 NA LIGHT, SURGICAL, ACCESSORIES FTA STERIS CORPORATION STERILE LIGHTHANDLE COVER 206707822210 00724995150136

    Patients

    Seq Age Sex Outcome Treatment
    1