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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M HEALTH COMPANY 3M BAIR PAWS FLEX GOWN; SYSTEM, THERMAL REGULATING
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3M HEALTH COMPANY 3M BAIR PAWS FLEX GOWN; SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number 81003
Device Problem No Apparent Adverse Event (3189)
Patient Problem Irritation (1941)
Event Date 03/02/2015
Event Type  Injury  
Event Description
A nurse reported that an adult female, age unk, was warmed with a 3m bair paws flex gown in the outpatient ambulatory surgery ctr in (b)(6) 2015.There was no skin prep reported.When the pt was assessed in the operating room, she was alleged to have redness and itching where the gown touched the skin.She was given an injectable benadryl (diphenhydramine) because she could not take oral medications in the operating room.The reporter does not have the gown used nor the lot number.The warming unit was not tested by the biomed and the model number/serial number of the warning unit remains unk.
 
Manufacturer Narrative
No lot number was provided.Without this info, it is not possible to determine the expiration date of manufacture date of the product used.
 
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Brand Name
3M BAIR PAWS FLEX GOWN
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
3M HEALTH COMPANY
st. paul MN 55144
Manufacturer Contact
linda johnsen
3m center
bldg. 275-5w-06
st. paul, MN 55144-1000
6517374376
MDR Report Key4690193
MDR Text Key5646607
Report Number2110898-2015-00017
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060865
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number81003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
WARMING UNIT (MODEL NUMBER NOT SPECIFIED)
Patient Outcome(s) Other;
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