BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL TOCO+ MP

    MDR report key: 10755041 · Received October 28, 2020

    Report

    Report Number
    MW5097519
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 23, 2020
    Report Date
    October 26, 2020
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    HFM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PLASTIC COVERING FELL OFF TO MONITORING DEVICE CAUSING SKIN REACTION TO ABDOMEN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214217 PHILIPS MEDICAL TOCO+ MP MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC) HFM PHILIPS NORTH AMERICA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR