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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG LEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEM SYSTEM, THERMAL REGULATING

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SMITHS HEALTHCARE MFG LEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEM SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number SWU-2003
Device Problem Insufficient Information (3190)
Patient Problem Burn(s) (1757)
Event Date 06/16/2016
Event Type  Injury  
Manufacturer Narrative
Smiths medical has received the sample device and is currently being evaluated. The manufacturer will file a follow up report detailing the result of the evaluation once it is completed.
 
Event Description
This event occured in (b)(6). According to reporter, the device was in use for warming of patient during nasal surgery for an hour and 9 minutes. The reporter stated that after the surgery, the patient showed: reddened areas noted on chest, legs and primarily on abdomen where product had direct skin contact. No blisters noted but reddened areas on abdomen matched the functionality design of the blanket. Patient stated that he had no pain from the affected site during follow up in recovery room. No permanent adverse effects to patient reported. Unknown patient's condition at this time.
 
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Brand NameLEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEM
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana 55425
MX 55425
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana 55425
MX 55425
Manufacturer Contact
lisa perz
1265 grey fox rd
st. paul, MN 55112
7633833074
MDR Report Key5796502
MDR Text Key49615892
Report Number2183502-2016-01481
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K011907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2019
Device Catalogue NumberSWU-2003
Device Lot Number3184607
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/06/2016
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: 07/14/2016 Patient Sequence Number: 1
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