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U.S. Department of Health and Human Services

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

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3M HEALTH CARE 3M BAIR HUGGER(TM) THERAPY ADULT LOWER BODY BLANKET WARMING BLANKET Back to Search Results
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.
 
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Brand Name3M BAIR HUGGER(TM) THERAPY ADULT LOWER BODY BLANKET
Type of DeviceWARMING 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 Key5574481
MDR Text Key42569384
Report Number2110898-2016-00048
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041686
Number of Events Reported1
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 Received04/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number525
Device Catalogue Number52500
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 Received10/25/2017
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 Treatment Data
Date Received: 04/13/2016 Patient Sequence Number: 1
Treatment
3M BAIR HUGGER UPPER BODY BLANKET
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