MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC. SUNBEAM; HEATING PAD

Model Number 770

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, "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 his bed mattress pad melted while using his heating pad and received burns on his back.

Manufacturer Narrative

Establishment registration #: 0008010316.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.Consumer admits to sleeping while using the heating pad which is a violation of the instructions and warnings provided.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.Heating pad is bunched/folded 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.- attachment: [23541-investigation form-master 2.Pdf].

Event Description

Consumer alleges his bed mattress pad melted while using his heating pad and received burns on his back.

• Brand Name: SUNBEAM
• Type of Device: HEATING PAD
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC.; 2381 executive center dr.; boca raton, fl FL 33431
• MDR Report Key: 9627556
• MDR Text Key: 176259810
• Report Number: 3007790958-2020-00006
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

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 Number: 770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other