MAUDE Adverse Event Report: SUNBEAM/NEWELL BRAND/XIE KANG / SUNBEAM PRODUCTS, INC. SUNBEAM (12" X 24") KING SIZE BLUE HEATING PAD; PAD, HEATING, POWERED

Model Number 938-511-000U

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Melted (1385); Device Emits Odor (1425)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 06/03/2021

Event Type  Injury  

Event Description

Heating pad connector shorted out causing a possible fire and severe injury.I was lying in bed with the heating pad underneath my lower back for less than an hour.I began to smell a horrible odor.Upon investigation, discovered the burnt/melting connector which singed bottom bed sheet and pillowcases.I have provided photos.I believe that the pillows and the position of the connector (not being directly underneath my back) both saved me from severe burn injuries.I have used this type of sunbeam heating pad for years, without this type of life-threatening situation.I have also learned that after months of usage, the heating pad remote control red light continuously flashes (indicating electrical issues).Thereby rendering the pad useless and requiring replacement.I am certain that sunbeam is already aware of their design flaw.I immediately opened a complaint claim with sunbeam/newell corporation, case #(b)(4).Sunbeam/newell brand/xie kang (12" x 24") king size blue heating pad, model #938-511-000u.Defective item was returned to vendor for testing, after consumer's request returned back after manufacturer's testing/findings.Consumer told item was damaged because heating pad should not be used for lower back.Fda safety report id# (b)(4).

• Brand Name: SUNBEAM (12" X 24") KING SIZE BLUE HEATING PAD
• Type of Device: PAD, HEATING, POWERED
• Manufacturer (Section D): SUNBEAM/NEWELL BRAND/XIE KANG / SUNBEAM PRODUCTS, INC.
• MDR Report Key: 12513595
• MDR Text Key: 272742248
• Report Number: MW5104146
• Device Sequence Number: 1
• Product Code: IRT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/20/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 938-511-000U
• Device Lot Number: XK-03 E236618
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ECOTRIN 81MG; TEMAZEPAM 30 MG; TOPROL XL 50 MG; VITAMIN D3
• Patient Outcome(s): Life Threatening
• Patient Age: 67 YR
• Patient Weight: 89