MAUDE Adverse Event Report: BEDSURE/WUXI SHINEBED GLOBAL E-COMMERCE CO.,LTD HEATING PAD; PAD, HEATING, POWERED

Model Number BS-HP1224

Device Problems Thermal Decomposition of Device (1071); Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 01/10/2023

Event Type  Injury  

Event Description

Heating pad burned a hole in mattress.Device plugged in but turned off.

• Brand Name: HEATING PAD
• Type of Device: PAD, HEATING, POWERED
• Manufacturer (Section D): BEDSURE/WUXI SHINEBED GLOBAL E-COMMERCE CO.,LTD; 36 w 25th st,; 16th floor; new york NY 10010
• MDR Report Key: 16185776
• MDR Text Key: 307634256
• Report Number: MW5114338
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/12/2023

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
• Device Model Number: BS-HP1224
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Female