BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEE SIGHT

    MDR report key: 7991512 · Received October 22, 2018

    Report

    Report Number
    1218950-2018-07691
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Report Date
    September 25, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HJN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER NOT PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE WEE SIGHT THAT WAS STORED IN HER PURSE AND MELTED. THERE WAS NO REPORTED PATIENT INCIDENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830313 WEE SIGHT TRANSILLUMINTOR, BATTERY-POWERED HJN PHILIPS MEDICAL SYSTEMS 1017920 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1