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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CINCINNATI SUB ZERO PRODUCTS, INC. MAXI-THERM LITE; SYSTEM, THERMAL REGULATING
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CINCINNATI SUB ZERO PRODUCTS, INC. MAXI-THERM LITE; SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number 876
Device Problem Insufficient Information (3190)
Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Event Date 02/04/2016
Event Type  Injury  
Manufacturer Narrative
 
Event Description
Patient had 14 hour operating room time earlier this month.Approximately 2 days later, the patient noted to have reddened upper back, which then evolved several rows of round circles in a linear pattern across the back.It appeared to have been caused by some type of pad the patient was lying on in operating room.Mono bi-polar grounding pad also used on back.The area was inspected by the md and wound care rn and it was determined that this was a combination of first degree and second degree burn in the same pattern as the therm-lite blanket.
 
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Brand Name
MAXI-THERM LITE
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
CINCINNATI SUB ZERO PRODUCTS, INC.
12011 mosteller rd
cincinnati OH 45241
MDR Report Key5488790
MDR Text Key39977357
Report Number5488790
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 Other
Type of Report Initial
Report Date 02/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2016
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Catalogue Number876
Device Lot Number765128
Other Device ID Number56440-F
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/24/2016
Event Location Hospital
Date Report to Manufacturer02/24/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
OTHER, ANESTHESIA, PT INTUBATED HAVING LENGTHY HE
Patient Outcome(s) Other;
Patient Age71 YR
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