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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITH MEDICAL SNUGGLE WARM UPPER BODY BLANKET; WARMING BLANKET
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SMITHS MEDICAL ASD, INC. SMITH MEDICAL SNUGGLE WARM UPPER BODY BLANKET; WARMING BLANKET Back to Search Results
Device Problem Unknown (for use when the device problem is not known) (2204)
Patient Problem Blister(s) (1743)
Event Date 08/26/2014
Event Type  Injury  
Event Description
Risk received a call from pacu that they had just received a pt from the operating room that had a burn from the warming blanket during surgery.When arrived in the pacu, the pt had blister and red marks along both arms and across the back.The pt had a spinal surgery.The blisters were primarily on the right arm and a few on the right side of the back near the upper back.There were red marks along the left back and arm.The forced air was attached to the warming blanket on the left side of the pt with the blisters developing on the pt's right side.By the time the blisters appeared the warming blanket had already been discarded so i do not have any lot numbers or identifying numbers to report.
 
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Brand Name
SMITH MEDICAL SNUGGLE WARM UPPER BODY BLANKET
Type of Device
WARMING BLANKET
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
5200 upper metro place
ste 200
dublin OH 43017
MDR Report Key4115414
MDR Text Key4837051
Report Number4115414
Device Sequence Number1
Product Code DWJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/08/2014
Distributor Facility Aware Date08/26/2014
Event Location Hospital
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age66 YR
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