BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OWLET MONITOR

    MDR report key: 12924940 · Received December 2, 2021

    Report

    Report Number
    MW5105758
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    July 10, 2021
    Report Date
    November 30, 2021
    Manufacturer
    OWLET BABY CARE, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PERMANENT DISFIGUREMENT; WE PUT THE OWLET MONITOR ON OUR BABY'S FOOT AS INSTRUCTED BY THE MANUFACTURER. THE FOOT DEVELOPED REDNESS WHICH STARTED BUBBLING UP. WE IMMEDIATELY STOPPED USING IT. NOW IT HAS BEEN MONTHS AND THERE IS STILL RED BUBBLES COVERING THE AREA WHICH THE OWLET WAS ON. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816622 OWLET MONITOR OWLET MONITOR DQA OWLET BABY CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 19 DA Female Other