MAUDE Adverse Event Report: AUGUSTINE TEMPERATURE MANAGEMENT, LLC HOTDOG PATIENT WARMING BLANKET; SYSTEM, THERMAL REGULATING

Model Number B105

Device Problem Melted (1385)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2021

Event Type  Injury  

Event Description

It was observed that a reusable patient warming blanket had multiple areas where the exterior cover had melted.Fda safety report id #(b)(4).

• Brand Name: HOTDOG PATIENT WARMING BLANKET
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): AUGUSTINE TEMPERATURE MANAGEMENT, LLC
• MDR Report Key: 13019759
• MDR Text Key: 282420972
• Report Number: MW5106110
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: B105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention