MAUDE Adverse Event Report: DRIVE; HEATING PAD

Device Problem Insufficient Information (3190)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 11/16/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a heating pad by two end users, who stated that they sustained "second and third degree burns when their rv caught on fire." the end users also stated that "it is our belief the fire was due to a malfunctioning drive digital heating pad." the end users did not provide any additional details regarding the basis for their belief that the heating pad caused the fire, or any further information regarding medical treatment.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: HEATING PAD
• MDR Report Key: 17399171
• MDR Text Key: 319801344
• Report Number: 2438477-2023-00101
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2023,06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2023
• Distributor Facility Aware Date: 06/28/2023
• Date Report to Manufacturer: 07/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1