MAUDE Adverse Event Report: 3M COMPANY BAIR HUGGER; SYSTEM, THERMAL REGULATING

Model Number 775

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Sweating (2444); Burn, Thermal (2530)

Event Date 03/04/2020

Event Type  malfunction  

Event Description

Patient diaphoretic and flushed.Operating room rn stated the bair hugger was on the patient.Patient also noted to have a patterned red rash or burn on her inner left thigh believed to be from the use of the bair hugger.

• Brand Name: BAIR HUGGER
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave; bldg. 275-5w-06 MN 55144
• MDR Report Key: 10118197
• MDR Text Key: 193974885
• Report Number: 10118197
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2020

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
• Device Operator: No Information
• Device Model Number: 775
• Device Catalogue Number: 77500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17520 DA