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.

• 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
• Reporter Occupation: Risk Manager
• 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

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 81003
• Device Catalogue Number: 81003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 01/15/2019 Patient Sequence Number: 1