MAUDE Adverse Event Report: UNION COMMON WAY INTL CORP DRIVE; HEATING PAD

Model Number	10890
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) healthcare was notified of an incident involving a heating pad by an end user, who stated that "she was sleeping when the fuse blew and burned on her lower back." she did not seek medical care, and treated the burn with neosporin.The end user did not specify whether she was lying on the heating pad when the incident occurred, in contravention of warnings.Although a replacement was provided, along with a free mailing label to return the affected unit, the unit was never returned for evaluation.

• Brand Name: DRIVE
• Common Device Name: HEATING PAD
• Manufacturer (Section D): UNION COMMON WAY INTL CORP; 11f-7,no.296,sec.2,chung shan; chung ho dist; new taipei city, taipei 235 ; TW 235
• MDR Report Key: 15573665
• Report Number: 2438477-2022-00104
• Device Sequence Number: 12281389
• Product Code: IRT
• UDI-Device Identifier: 00822383123882
• UDI-Public: 00822383123882
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2022
• Report Date (Section F): 10/10/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 10890
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/03/2021
• Device Age: 5 MO
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 64 KG
• Date Report Sent to FDA: 10/10/2022