BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIGHTY BLISS HEATING PAD

    MDR report key: 15855545 · Received November 22, 2022

    Report

    Report Number
    MW5113444
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    November 18, 2022
    Report Date
    November 18, 2022
    Manufacturer
    WHELE, LLC.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE WERE ADVISED OF PRODUCT RECALL VIA AMAZON BUT THE COMPANY RECALL SITE LINK IS NOT RECOGNIZING OUR AMAZON ORDER NUMBER BUT THERE WAS IN FACT A RECALL. : HTTPS://WWW.FDA.GOV/SAFETY/RECALLS-MARKET-WITHDRAWALS-SAFETY-ALERTS/WHELE-LLC-ANNOUNCES-NATIONAL-VOLUNTARY-RECALL-MIGHTY-BLISS-ELECTRIC-HEATING-PAD-DUE-PRODUCT-SAFETY. FDA SAFETY REPORT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796814 MIGHTY BLISS HEATING PAD PAD, HEATING, POWERED IRT WHELE, LLC. NA-H21B 210301

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female