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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCOMPASS GROUP, LLC NOVA PATIENT WARMING SYSTEM

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ENCOMPASS GROUP, LLC NOVA PATIENT WARMING SYSTEM Back to Search Results
Model Number AW5100-300
Device Problem Insufficient Information (3190)
Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Event Date 06/17/2021
Event Type  Injury  
Manufacturer Narrative
Note: report delayed due to delayed sign up process; first time submitting adverse event.
 
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Brand NameNOVA
Type of DevicePATIENT WARMING SYSTEM
Manufacturer (Section D)
ENCOMPASS GROUP, LLC
615 macon street
mcdonough GA 30253
Manufacturer (Section G)
ENCOMPASS GROUP, LLC
615 macon street
mcdonough GA 30253
Manufacturer Contact
jessica lester
615 macon street
mcdonough, GA 30253
7706262172
MDR Report Key12216778
MDR Text Key263392550
Report Number1043644-2021-00001
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K203085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Administrator/Supervisor
Remedial Action Other
Type of Report Initial
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberAW5100-300
Device Lot Number1971322
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
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 Initial

Patient Treatment Data
Date Received: 07/23/2021 Patient Sequence Number: 1
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