MAUDE Adverse Event Report: NINGBO JUSTLIVE ELECTRICAL APPLIANCE CO., LTD DRIVE; HEATING PAD

Model Number	RTLAGF-HP-STD
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a heating pad on january 30th.The initial reporter stated that her mom "received burns from a heating pad" on her arm and " has been in pain from blistering." the unit has not been returned for evaluation and no additional information is available at this time.Drive devilbiss healthcare is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update as soon as additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: HEATING PAD
• Manufacturer (Section D): NINGBO JUSTLIVE ELECTRICAL APPLIANCE CO., LTD; no. 77, ketai rd.; wangchun industrial park,; haishu district, ningbo zhejiang, 31517 1; CH 315171
• MDR Report Key: 13656593
• Report Number: 2438477-2022-00011
• Device Sequence Number: 1944574
• Product Code: IRT
• UDI-Device Identifier: 00822383511160
• UDI-Public: 822383511160
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 03/02/2022
• Report Date (Section F): 03/02/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: RTLAGF-HP-STD
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/30/2022
• Device Age: 34 MO
• Event Location: Home
• Date Report to Manufacturer: 03/03/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 03/02/2022