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

Model Number	RTLAGF-HD-STD
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, drive received a medwatch report, related to a heating pad.The medwatch report was completed on (b)(6) 2021.The end user reported that "the unit felt like it was getting too hot, so i removed it.I then noticed the unit smoking, so i immediately unplugged it and then noticed burn marks on the plastic inner cover and the other cloth cover." drive 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.
Event or Problem Description
On (b)(6), 2022, drive received a medwatch report relating to a heating pad.In the medwatch report, the end user reported that "the unit felt like it was getting too hot, so i removed it.I then noticed the unit smoking, so i immediately unplugged it and then noticed burn marks on the plastic inner cover and the other cloth cover." drive 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 i; industrial park, haishu distr; ningbo, zhejiang, 31517 1; CH 315171
• MDR Report Key: 13654927
• Report Number: 2438477-2022-00005
• Device Sequence Number: 2369503
• Product Code: IRT
• UDI-Device Identifier: 00822383511160
• UDI-Public: 822383511160
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup
• Report Date (Section B): 03/04/2022
• Report Date (Section F): 03/04/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: RTLAGF-HD-STD
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/24/2022
• Event Location: Home
• Date Report to Manufacturer: 03/07/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 03/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 03/04/2022