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

Model Number 2004-703

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

Patient Problem Burn(s) (1757)

Event Date 01/24/2021

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.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.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, "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 letter notice alleging that a heating pad was the cause of a burn to its client's left lower back/upper buttocks area.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
• Manufacturer (Section G): ZHEIJANG LUMENG HEALTH & TECHNOLOGY CO., LTD; northwest of qunxian road and; center avenue; paojiang, 31200 ; CH 31200
• Manufacturer Contact: michael miles ; 303 nelson ave.; neosho, MO 64850 ; 4174557441
• MDR Report Key: 14306049
• MDR Text Key: 290928873
• Report Number: 3010805625-2022-00023
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2004-703
• 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 Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male