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

Model Number	731-500
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer alleges her heating pad caught on fire while using on her couch and caused damage to her couch.There was not a report of personal injury with this incident.
Additional Manufacturer Narrative
Consumer discarded the product.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, "do not tuck in, trap, fold, cross, pinch or wrap control or cord within the heating pad or any other insulating material during use" 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): SKY EAGLE HOLDINGS CORP.; no. 128, chung hwa rd., sec.2; taipei hsien 236 ; TW
• Manufacturer Contact: michael miles ; 303 nelson ave.; neosho, MO 64850 ; 4174557441
• MDR Report Key: 16626846
• Report Number: 3007790958-2023-00024
• Device Sequence Number: 4474537
• Product Code: IRT
• UDI-Device Identifier: 00053891134019
• UDI-Public: (01)00053891134019(11)220426
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 731-500
• 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: 03/28/2023
• 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
• Patient Sex: Female