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

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

Patient Problems Itching Sensation (1943); Rash (2033); Skin Irritation (2076); Swelling (2091)

Event Date 11/14/2019

Event Type  Injury  

Event Description

Pt called to report adverse event involving the bair hugger warming blanket.Pt stated the device was used on her when she was in the hosp for shoulder surgery.Pt stated she did not ask for the device to be used but was assured it was safe and would help keep her warm.Pt said after her surgery, she developed a rash all over her body.Pt stated her rash has become worse and she is in agony, suffering from the itchy, pustular blisters.Pt said they look like cuts on her skin.Pt was recently put on antibiotics but is concerned about developing infections.Pt believes the material that the device is made of contains something harmful to her skin.

• Brand Name: BAIR HUGGER BLANKET
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 9349216
• MDR Text Key: 167388642
• Report Number: MW5091199
• 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: Patient
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR