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

Model Number 81003

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

Patient Problem Rash (2033)

Event Date 12/14/2018

Event Type  malfunction  

Event Description

Patient has small dot rash over bair hugger area on chest.No itching or welts, or pain noted this has been a recurring event over the last few weeks.Bair hugger gowns have been used for years.

Event Description

Patient has small dot rash over bair hugger area on chest.No itching or welts, or pain noted this has been a recurring event over the last few weeks.Bair hugger gowns have been used for years.

• Brand Name: BAIR HUGGER FLEX WARMING GOWN
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave.; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 8247977
• MDR Text Key: 133113018
• Report Number: 8247977
• 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
• Type of Report: Initial,Followup
• Report Date: 01/01/2019,12/31/2018

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: 81003
• Device Catalogue Number: 81003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22265 DA