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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PACIFIC SHORE HOLDINGS, INC. THERMAL AID; THERMAL AID 100 PERCENT NATURAL HEATING AND COOLING PACK PINK BEAR
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PACIFIC SHORE HOLDINGS, INC. THERMAL AID; THERMAL AID 100 PERCENT NATURAL HEATING AND COOLING PACK PINK BEAR Back to Search Results
Model Number PINK BEAR
Device Problems Fire (1245); Device Emits Odor (1425); Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/27/2016
Event Type  Other  
Event Description
On (b)(6) 2016 the submitter's grandfather was sick with the flu.The submitter's daughter put the bear in the microwave for 45 seconds and then went to go put the bear on her child's stomach.However, the submitter's granddaughter was sleeping.The submitter's daughter decided to put the bear on her neck.The submitter's daughter noticed a burn odor.The submitter's daughter wrapped the bear in a towel and placed it in the laundry basket.Approximately 10 minutes later the submitter's daughter and son-in-law noticed a strong burn odor.When they checked the laundry room they noticed the bear and nearby clothes were in flames.The laundry basket was taken out of the home.The submitter states the top half of the bear is completely burned.The submitter does not plan to contact the firm directly.The submitter states that her granddaughter has played with the bear as a toy but the submitter is not sure if the bear has ever been put in the microwave before (b)(6) 2016.The submitter believes the bear is defective.Incident location: home/apartment/condominium - (b)(6), united states.Retailer: (b)(6).Retailer state: (b)(6).Purchase date: (b)(6) 2015.The product was not damaged before the incident.(b)(4).
 
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Brand Name
THERMAL AID
Type of Device
THERMAL AID 100 PERCENT NATURAL HEATING AND COOLING PACK PINK BEAR
Manufacturer (Section D)
PACIFIC SHORE HOLDINGS, INC.
MDR Report Key5566819
MDR Text Key42305422
Report NumberMW5061576
Device Sequence Number1
Product Code IME
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 02/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2016
Device Operator No Information
Device Model NumberPINK BEAR
Was Device Available for Evaluation? No
Type of Device Usage N
Patient Sequence Number1
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