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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CINCINNATI SUB-ZERO PRODUCTS, INC. BLANKETROL® LLL; SYSTEM, THERMAL REGULATING
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CINCINNATI SUB-ZERO PRODUCTS, INC. BLANKETROL® LLL; SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 233
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
Event Date 01/06/2020
Event Type  Injury  
Event Description
Patient noted to have multiple, uniform, imprinted, serous filled blisters on left lateral calf.Appears to be a burn in the shape of the blanketrol padding.Area was offloaded, turned and repositioned appropriately.This happened within a very short window of time.Unsure of temperature at time of injury.Temperatures documented in epic appeared to be in appropriate ranges.Biomed paged to assess device, device switched to manual setting (previously on automatic) and will be removed.Blanketrol was removed from service and tested by (b)(6).Found to have no issues/defects.
 
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Brand Name
BLANKETROL® LLL
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
CINCINNATI SUB-ZERO PRODUCTS, INC.
12011 mosteller road 3rd floor
blue ash OH 45241
MDR Report Key9610495
MDR Text Key175676294
Report Number9610495
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number233
Device Catalogue Number86107
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/10/2020
Event Location Hospital
Date Report to Manufacturer01/21/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age24455 DA
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