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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Event Description

The 3m air blanket is used before, during, and after a procedure to keep a patient warm.The patient states that the doctors were not using the device according to manufacturer guidelines.She goes on to state that she woke up from the anesthesia and felt as if she was cooking.The doctors did a temperature reading on the patient and performed active cooling for 10 minutes.The patient believes that her temperature might have been close to 100 degrees which she says is higher than her normal baseline temperature of 96 degrees respectively.After the cooling had finished, she stated that her discharge temperature was 97.She said the event occurred at (b)(6) hospital.She also stated that a potential sexual assault occurred before her procedure and incidentally the cameras in the operating room were not functioning to capture any of it.

• Brand Name: 3M AIR BLANKET
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): 3M COMPANY; saint paul MN
• MDR Report Key: 6916139
• MDR Text Key: 88448757
• Report Number: MW5072621
• 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: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event 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; Required Intervention
• Patient Weight: 64