TCC-EZ CASTING SYSTEM 4" SINGLE APPLICATION TCC24002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-11-21 for TCC-EZ CASTING SYSTEM 4" SINGLE APPLICATION TCC24002 manufactured by Derma Sciences, Inc..

Event Text Entries

[128114463] The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10


[128114464] It was reported that a tcc24002 tcc-ez casting system caused a wound on the toe from the cast caving in and rubbing the skin. Customer states that the casts are not warming and hardening like they used to. Medical intervention was required to treat the wound and the patient was re-casted. 4 of 5 reports - other mfg report numbers: 9680091-2018-00034, 9680091-2018-00035, 9680091-2018-00036, 9680091-2018-00038.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9680091-2018-00037
MDR Report Key8096709
Report SourceUSER FACILITY
Date Received2018-11-21
Date of Report2018-11-06
Date Mfgr Received2018-11-23
Date Added to Maude2018-11-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUSER VIVIAN NELSON
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1DERMA SCIENCES, INC.
Manufacturer Street104 SHORTING ROAD
Manufacturer CityTORONTO, ONTARIO M1S 3S4
Manufacturer CountryCA
Manufacturer Postal CodeM1S 3S4
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTCC-EZ CASTING SYSTEM 4" SINGLE APPLICATION
Generic NameTCC-EZ
Product CodeITG
Date Received2018-11-21
Catalog NumberTCC24002
Lot Number0618006
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDERMA SCIENCES, INC.
Manufacturer Address104 SHORTING ROAD 104 SHORTING ROAD TORONTO, ONTARIO M1S 3S4 CA M1S 3S4


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-21

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