COZY HUGS RN# 128924

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for COZY HUGS RN# 128924 manufactured by Unknown.

Event Text Entries

[141602578] I bought a monster-style cozy hugs aromatherapy stuffed toy from a retail store tonight. The directions indicated the removable pouch could be heated in the microwave for up to one minute or cooled in the freezer overnight and replaced into the animal, for soothing purposes. The contents are listed as ceramic beads and lavender. I tried heating it in the microwave. After just a few seconds, it flashed and made a horrendous sound in the microwave. I thought it might catch on fire. I was unsure if the problem was with the pouch or the microwave, so i removed it and tried microwaving a cup of water, which worked. I tried the pouch again, and had the same scary result. This was the only one of its style on the shelves, but there were at least 6 other cozy hugs animals in different animal shapes. I planned to take it back tomorrow, but your form indicates that i should hold it for 30 days. Product description: cozy hugs jumbo soothing aromatherapy freezable and microwavable stuffed item. States on packaging " this product is not a toy" sold in baby/child department, section with toys/slippers/stuffed animals/soothing items. Manufacturer website: https://www. Goldessencelimited. Com/products. Goldessence limited. Retailer: (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085705
MDR Report Key8497217
Date Received2019-04-08
Date of Report2019-02-08
Date of Event2019-02-08
Date Added to Maude2019-04-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCOZY HUGS
Generic NamePACK, HOT OR COLD, REUSABLE
Product CodeIME
Date Received2019-04-08
Model NumberRN# 128924
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-08

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