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

Model Number	535-912
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
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.There is an instruction that states, "do not sit on, against, or crush pad-avoid sharp folds" and consumer failed to perform that instruction.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" and consumer failed to perform that instruction.
Event or Problem Description
Consumer alleges she used the heating pad in her bedroom for stomach and back pains then received a burn on her right butt cheek.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.There is an instruction that states, "do not sit on, against, or crush pad-avoid sharp folds" and consumer failed to perform that instruction.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" and consumer failed to perform that instruction.There is an instruction that states, "place pad on top of and not under the part of body needing heat" and consumer failed to perform that instruction.This incident is the direct result of consumer misuse/abuse of the product.
Event or Problem Description
Consumer alleges she used the heating pad in her bedroom for stomach and back pains then received a burn on her right butt cheek.There was not a report of property damage with this incident.

• Brand Name: WALGREENS
• 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: 15905753
• Report Number: 3007790958-2022-00048
• Device Sequence Number: 17443370
• Product Code: IRT
• UDI-Device Identifier: 00311917167602
• UDI-Public: (01)00311917167602(11)181030
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 12/13/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 535-912
• Device Catalogue Number: 000535-912-001U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2018
• 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