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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DERMA SCIENCES, INC. TCC-EZ CASE OF 10 CASTING SYSTEMS 3" NO BOOT
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DERMA SCIENCES, INC. TCC-EZ CASE OF 10 CASTING SYSTEMS 3" NO BOOT Back to Search Results
Catalog Number TCC23001
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.
 
Event Description
It was reported that the bottom of the cast failed to harden.The cast flattens out when used with boot for ambulation.No patient injury was reported.Application procedure was reviewed at the clinic with no application flaws noted.
 
Manufacturer Narrative
The complaint product was not returned for evaluation.Dhr was reviewed with lot number 0218013.After reviewing the batch records, there were no deviations found in the production process or in the finished goods inspection.The product was released without quality issues failure analysis unconfirmed; root cause undetermined as no product was returned.
 
Event Description
N/a.
 
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Brand Name
TCC-EZ CASE OF 10 CASTING SYSTEMS 3" NO BOOT
Type of Device
TCC-EZ
Manufacturer (Section D)
DERMA SCIENCES, INC.
104 shorting road
104 shorting road
toronto, ontario M1S 3 S4
CA  M1S 3S4
MDR Report Key7661236
MDR Text Key113185370
Report Number9680091-2018-00020
Device Sequence Number1
Product Code FRO
Combination Product (y/n)N
PMA/PMN Number
K133279
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberTCC23001
Device Lot Number0218013
Was Device Available for Evaluation? No
Date Manufacturer Received07/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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