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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TSCI BV DBA THE 37COMPANY PREMIUM ADULT - SYK; SYSTEM, THERMAL REGULATING
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TSCI BV DBA THE 37COMPANY PREMIUM ADULT - SYK; SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number MA3320-PM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Date 03/13/2019
Event Type  malfunction  
Event Description
It was alleged by the bme technician that when the bovie pad was connected to him and someone else pushed the bovie pen he could potentially burn/melt the reflective layer of the ma3320-pm blanket.This only appeared to occur when the tip of one of his fingers touched the blanket.If more than just a directed piece of his finger touched the blanket it would not occur.However, when putting just the tip of his finger on the blanket it would allegedly burn/melt every time.The bme technician allegedly received a burn with no required medical intervention.No patient injury was identified during the initial report of problem.
 
Event Description
It was alleged by the bme technician that when the bovie pad was connected to him and someone else pushed the bovie pen he could potentially burn/melt the reflective layer of the ma3320-pm blanket.This only appeared to occur when the tip of one of his fingers touched the blanket.If more than just a directed piece of his finger touched the blanket it would not occur.However, when putting just the tip of his finger on the blanket it would allegedly burn/melt every time.The bme technician allegedly received a burn with no required medical intervention.No patient injury was identified during the initial report of problem.
 
Manufacturer Narrative
After investigation, the cause for the alleged burn on the tip of the finger of the biomedical technician was found not to be related to a defect with the product (no defect alleged).It was identified through the inspection details and the labeling review that this issue may be attributed to the skin coming into contact with the reflective surface, which is cautioned against in the instructions for use.The biomedical technician did not seek any medical attention and did not self treat his injury.This issue was resolved by providing information that the skin should not come into contact with the reflective surface as indicated in the instructions for use.H3 other text : device not returned.
 
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Brand Name
PREMIUM ADULT - SYK
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
TSCI BV DBA THE 37COMPANY
beeldschermweg 6f
ah amersfoort 03821
NL  03821
MDR Report Key8506005
MDR Text Key142194592
Report Number3003312341-2019-00003
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberMA3320-PM
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MA1100-PM, MISTRAL-AIR PLUS (115V) BLOWER
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