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

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

Patient Problem Burn(s) (1757)

Event Type  Injury  

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.

Event Description

Per fda complaint report number mw5087474, consumer alleges their heating pad caused a serious injury to their body.There was not a report of property damage with this incident.

• 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 ; TW 236
• Manufacturer Contact: michael miles ; 303 nelson ave.; neosho, MO 64850 ; 4174557441
• MDR Report Key: 8803160
• MDR Text Key: 151456241
• Report Number: 3007790958-2019-00052
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2019

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: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other