FDA Adverse Event Malfunction Summary report: N

MIGHT BLISS ELECTRIC HEATING PAD

MDR report key: 18686155 · Received February 9, 2024

Report

Report Number
MW5151352
Event Type
Malfunction
Date Received
February 9, 2024
Date of Event
November 28, 2023
Report Date
February 7, 2024
Manufacturer
WHELE LLC.
Product Code
IRT
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

THIS UNIT (MIGHTY BLISS HEATING PAD NA-H1121B) WAS RECEIVED AS A GIFT AFTER MY WIFE WAS IN A CAR ACCIDENT. IT JUST STOPPED WORKING. AFTER LOOKING ONLINE FOR WARRANTY INFORMATION, I NOTICED AN FDA RECALL ON THIS UNIT. ATTEMPTS TO SUBMIT FOR A REFUND/REPLACEMENT WERE MADE EXTREMELY DIFFICULT BY THE COMPANY (WHELE/PERCH), AND EVENTUALLY THEY SAID THIS HAD BEEN ESCALATED. AFTER A MONTH WITH NO FOLLOW-UP, I CONTACTED THE COMPANY TO ASK THE STATUS. I RECEIVED THE SAME AUTOREPLY STATING THE CLAIM HAD BEEN ESCALATED. I EMAILED THEM BACK AND TOLD THEM THIS WAS NOT ACCEPTABLE, AND THAT IF I DID NOT HEAR BACK IN 3 WORKING DAYS, I WOULD SUBMIT A COMPLAINT WITH FDA. STILL NO RESPONSE, SO I PHONED THEM. THEY SAID THEY HAD NO RECORD OF MY CLAIM! I TOLD THEM I HAD MULTIPLE EMAIL EXCHANGES WITH THEM AND THAT I COULD FORWARD THESE EMAILS. THEY THEN SAID IF THE CLAIM HAD BEEN ESCALATED, THEN I JUST HAD TO WAIT TO HEAR FROM THEM. I SAID IT WAS ESCALATED A MONTH AGO, AND THAT THIS TIME FRAME RESPONSE WAS NOT REASONABLE, ESPECIALLY AS THEY GAVE ME NO TIME LINE AS TO WHEN TO EXPECT A RESPONSE. IN MY EXPERIENCE WITH THIS COMPANY, THEY DO EVERYTHING POSSIBLE TO AVOID HAVING TO HONOR THIS RECALL, AND THEY SHOULD BE INVESTIGATED FOR THIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2136684 MIGHT BLISS ELECTRIC HEATING PAD PAD, HEATING, POWERED IRT WHELE LLC. NA-H1121B 210910

Patients

Seq Age Sex Outcome Treatment
1 60 YR Female