MAUDE Adverse Event Report: 3M HEALTH CARE 3M BAIR HUGGER(TM) THERAPY ADULT LOWER BODY BLANKET WARMING BLANKET

Model Number 525

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 03/16/2016

Event Type  Injury  

Manufacturer Narrative

The warming unit model used with the blanket was not provided. No lot number was provided. Without lot number it is not possible to determine the expiration or manufacture date of the product. Additional information has been requested of the hospital as to the warming unit that was used with the blanket. The product instructions for use includes the following warning statement. "do not place the non-perforated side of the blanket on the patient. Thermal injury may result. Always place the perforated side (that is, with small holes) towards the patient. " the lower body blanket is intended to cover the lower body. Placement of the leg on top of the blanket would not be in accordance with its intended use. The user facility did not follow the instructions for use.

Event Description

A male patient, age not specified, had right hip surgery in early (b)(6) 2016. The patient was lying laterally on his left side with a 3m bair hugger therapy upper body blanket on his chest and arms, and a 3m bair hugger therapy adult lower body blanket on his legs. The patient may have been malnourished at the time of surgery. The patient's hip surgery lasted 8 hours. During the surgery the patient's right leg was occasionally placed on the lower body blanket. Nothing unusual was noted following the surgery. Five days after the surgery the patient was alleged to have a 3rd degree burn on the inside knee bend of his right leg, requiring skin grafting.

Manufacturer Narrative

Information was received on patient as to the type of surgery and age of patient. Applicable sections of this report have been updated. This type of reported event is extremely rare and based on four years of data review this is the only complaint of this type as noted in the analysis section of the complaint.

Event Description

Published news article was received regarding the initial reported case. Within the article the patient was noted to be a (b)(6) year old who underwent a 6 hour right hemipelvectomy/hip amputation. The patient alleged third degree burns to the lower half of his body.

• Brand Name: 3M BAIR HUGGER(TM) THERAPY ADULT LOWER BODY BLANKET
• Type of Device: WARMING BLANKET
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY EDEN PRAIRIE; 10351 west 70th street; eden prairie MN 55344
• Manufacturer Contact: linda johnsen ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517374376
• MDR Report Key: 5574481
• Report Number: 2110898-2016-00048
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 525
• Device Catalogue Number: 52500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 64 YR
• Patient Treatment(s): 3M BAIR HUGGER UPPER BODY BLANKET
• Patient Outcome(s): Other