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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DERMA SCIENCES, INC. CAST REMOVAL SAW TCC OTHER

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DERMA SCIENCES, INC. CAST REMOVAL SAW TCC OTHER Back to Search Results
Catalog Number TCC2SAW
Device Problem Smoking (1585)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/15/2018
Event Type  Malfunction  
Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

 
Event Description

It was reported by the customer that on (b)(6) 2018, when cutting the cast off of a patient, the tcc2saw cast removal saw started to smoke and then stopped working. The customer borrowed a cast saw from an orthopedic doctor office nearby to complete the procedure. No patient injury were reported. Additional information was already requested.

 
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Brand NameCAST REMOVAL SAW
Type of DeviceTCC OTHER
Manufacturer (Section D)
DERMA SCIENCES, INC.
104 shorting road
104 shorting road
toronto, ontario M1S 3 S4
CA M1S 3S4
Manufacturer (Section G)
DERMA SCIENCES, INC.
104 shorting road
toronto, ontario M1S 3 S4
CA M1S 3S4
Manufacturer Contact
vivian nelson
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key7406543
MDR Text Key105255925
Report Number9680091-2018-00014
Device Sequence Number1
Product Code LGH
Combination Product (Y/N)N
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/16/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/09/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberTCC2SAW
Device LOT Number35160
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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