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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI SUNBEAM; HEATING PAD
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SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI SUNBEAM; HEATING PAD Back to Search Results
Model Number 731-500
Device Problem Insufficient Information (3190)
Patient Problem Burn(s) (1757)
Event Type  Injury  
Manufacturer Narrative
There is an instruction that states, "do not sit on, against, or crush pad-avoid sharp folds.Place pad on top of and not under the part of body needing heat" and consumer failed to perform that instruction.There is an instruction that states, "burns can occur regardless of control setting, check skin under pad frequently" and consumer failed to perform that instruction.
 
Event Description
Consumer alleges receiving burns on her back from using her heating pad.There was not a report of property damage with this incident.
 
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Brand Name
SUNBEAM
Type of Device
HEATING PAD
Manufacturer (Section D)
SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI
2381 executive center dr.
boca raton FL 33431
Manufacturer (Section G)
SKY EAGLE HOLDINGS CORP.
no. 128, chung hwa rd., sec. 2
taipei hsien, 236
TW   236
Manufacturer Contact
michael miles
303 nelson ave.
neosho, MO 64850
4174557441
MDR Report Key8185145
MDR Text Key131042481
Report Number3007790958-2018-00153
Device Sequence Number1
Product Code IRT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number731-500
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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