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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CINCINNATI SUB- ZERO PRODUCTS, LLC BLANKETROL SYSTEM, THERMAL REGULATING

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CINCINNATI SUB- ZERO PRODUCTS, LLC BLANKETROL SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number 874
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/29/2016
Event Type  malfunction  
Event Description
Small blanketrol water mattress was found to be leaking when removed from package and picked up to place over patient.   item removed and replaced.
 
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Brand NameBLANKETROL
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
CINCINNATI SUB- ZERO PRODUCTS, LLC
12011 mosteller rd.
cincinnati OH 45241
MDR Report Key6212377
MDR Text Key63504261
Report Number6212377
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2016
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number874
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/22/2016
Event Location Hospital
Date Report to Manufacturer11/22/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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