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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. LEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEMS SYSTEM, THERMAL REGULATING

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SMITHS MEDICAL ASD; INC. LEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEMS SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number SWU-2001
Device Problem Temperature Problem (3022)
Patient Problems Erythema (1840); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Event Date 07/01/2019
Event Type  Injury  
Event Description
Information was received indicating that upon removal of a smiths medical level 1® snuggle warm® blanket erythema was noted to the patient's arm, forearm, chest and abdomen. The right forearm was reported to show the beginning of phlycten. The clinician stated that the patient was well positioned on the blanket without any external constraint. The warmer was reported to set to 44 degrees celsius but the display had read 37 degrees celsius. Subsequently, biafine was prescribed for dressings. There were no further reported adverse effects.
 
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Brand NameLEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEMS
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis,, MN 55442
7633833310
MDR Report Key8848545
MDR Text Key152863861
Report Number3012307300-2019-03893
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K141686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSWU-2001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/24/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/31/2019 Patient Sequence Number: 1
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