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

Model Number 764-690

Device Problems Labelling, Instructions for Use or Training Problem (1318); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

Consumer alleges lain upon heating pad and fell asleep then awoke to a burn on the right side of her back.There was not a report of property damage with this incident.

Manufacturer Narrative

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

Consumer alleges lain upon heating pad and fell asleep then awoke to a burn on the right side of her back.There was not a report of property damage with this incident.

Manufacturer Narrative

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.Heating pad is bunched/crushed which shows abuse of the product and a violation of the instructions and warnings provided.This incident is the direct result of consumer misuse/abuse of the product.

• 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): SKY EAGLE HOLDINGS CORP.; no. 128, chung hwa rd., sec.2; taipei hsien 236 236 ; TW 236
• Manufacturer Contact: michael miles ; 303 nelson ave.; neosho, MO 64850 ; 4174557441
• MDR Report Key: 13559275
• MDR Text Key: 285829830
• Report Number: 3007790958-2022-00009
• Device Sequence Number: 1
• Product Code: IRT
• UDI-Device Identifier: 00053891133784
• UDI-Public: (01)00053891133784(11)210108
• 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,Followup
• Report Date: 12/14/2022

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: 764-690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2021
• 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