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

Model Number	938-511
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An attorney's 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.
Additional 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.

• Brand Name: SUNBEAM
• Common Device Name: 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: 16290811
• Report Number: 3010805625-2023-00013
• Device Sequence Number: 17363649
• Product Code: IRT
• UDI-Device Identifier: 00053891134040
• UDI-Public: (01)00053891134040(11)220617
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 938-511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female