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

Model Number 531

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

Patient Problem Burn(s) (1757)

Event Date 01/12/2022

Event Type  Injury  

Event Description

Consumer alleges she laid upon the heating pad while in bed and fell asleep then awoke to burns on her stomach.There was not a report of property damage with this incident.

Manufacturer Narrative

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

• Brand Name: WALGREENS
• Type of Device: HEATING PAD
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC.; 2381 executive center dr.; boca raton FL 33431
• Manufacturer (Section G): POWERTEK ELECTRONIC CO., LTD.; zhixiang bldg, 6th floor, 71 b; shenzhen, guangdong ; CH
• Manufacturer Contact: michael miles ; 303 nelson ave.; neosho, MO 64850 ; 4174557441
• MDR Report Key: 13506209
• MDR Text Key: 285456121
• Report Number: 3005477599-2022-00008
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2022

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: Lay User/Patient
• Device Model Number: 531
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2022
• 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: Female