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

Model Number 1958

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

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

A claims management office is filing a letter notice under case reference number (b)(4) alleging that a heating pad was the cause of a burn to its client's body.There was not a report of property damage with this incident.

Manufacturer Narrative

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 laying on the heating pad which is abuse of the product and a violation of the instructions and warnings provided.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.

Event Description

A claims management office is filing a letter notice under case reference number 9024736 alleging that a heating pad was the cause of a burn to its client's body.There was not a report of property damage with this incident.

• Brand Name: SUNBEAM
• Type of Device: HEATING PAD
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC.; 2381 executive center dr.; boca raton FL 33431
• MDR Report Key: 9495814
• MDR Text Key: 172033773
• Report Number: 3007790958-2019-00083
• 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: other
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other