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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL LEVEL 1 SYSTEM, THERMAL REGULATING

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ST PAUL LEVEL 1 SYSTEM, THERMAL REGULATING Back to Search Results
Model Number SWU-2010
Device Problem Temperature Problem (3022)
Patient Problem Superficial (First Degree) Burn (2685)
Event Date 06/01/2018
Event Type  Injury  
Event Description
Information was received indicating that during use of a smiths medical level 1 snuggle warm blankets convective warming system the patient was noted to be burned. It was reported that the burns were located on the body near where the hose's connection port was and that "medical treatment" was performed. There were no further reported adverse effects.
 
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Brand NameLEVEL 1
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key7652836
MDR Text Key242890221
Report Number3012307300-2018-02522
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K141686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 03/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberSWU-2010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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