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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC. SUNBEAM; HEATING PAD
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SUNBEAM PRODUCTS, INC. SUNBEAM; HEATING PAD Back to Search Results
Model Number 764
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn(s) (1757)
Event Type  Injury  
Manufacturer Narrative
There is an instruction that states, "this pad is not to be used on or by an invalid, a sleeping or unconscious person, a person with diabetes, or a person with poor blood circulation or insensitivity to heat, or a person incapacitated by medication" and consumer failed to perform that instruction.Consumer admits to laying on the heating pad which is abuse of the product and a violation of the instructions and warnings provided.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
An attorney's office is filing a court summons notice under case reference number (b)(6) alleging that a heating pad was the cause of a burn to its client's left hip.There was not a report of property damage with this incident.
 
Event Description
An attorney's office is filing a court summons notice under case reference number (b)(4) alleging that a heating pad was the cause of a burn to its client's left hip.There was not a report of property damage with this incident.
 
Manufacturer Narrative
There is an instruction that states, "this pad is not to be used on or by an invalid, a sleeping or unconscious person, a person with diabetes, or a person with poor blood circulation or insensitivity to heat, or a person incapacitated by medication" and consumer failed to perform that instruction.Consumer admits to laying on the heating pad which is abuse of the product and a violation of the instructions and warnings provided.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.Heating pad is bunched/crushed which shows abuse of the product and a violation of the instructions and warnings provided.This incident is the direct result of consumer misuse/abuse of the product.
 
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Brand Name
SUNBEAM
Type of Device
HEATING PAD
Manufacturer (Section D)
SUNBEAM PRODUCTS, INC.
2381 executive center dr.
boca raton FL 33431
MDR Report Key8636355
MDR Text Key145957960
Report Number3007790958-2019-00042
Device Sequence Number1
Product Code IRT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number764
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/23/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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