TECHFORM PREMIUM CAST TAPE 204WH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-14 for TECHFORM PREMIUM CAST TAPE 204WH manufactured by Bl Tech Co Ltd..

Event Text Entries

[4094132] While technician cut cast off patient, the cast removal created dust. The patient inhaled the dust and developed skin rash.
Patient Sequence No: 1, Text Type: D, B5


[11493452] Patient was provided with a topical steroid. We provided a copy of the msds to the practitioner.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2085446-2014-00001
MDR Report Key3597228
Report Source05
Date Received2014-01-14
Date of Report2014-01-14
Date of Event2013-11-26
Date Mfgr Received2013-12-19
Date Added to Maude2014-01-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactKAREN MONTES
Manufacturer Street27051 TOWNE CENTRE DR.
Manufacturer CityFOOTHILL RANCH CA 92610
Manufacturer CountryUS
Manufacturer Postal92610
Manufacturer Phone9493823741
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTECHFORM PREMIUM CAST TAPE
Generic NameBANDAGE, CAST
Product CodeITG
Date Received2014-01-14
Model Number204WH
Catalog Number204WH
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBL TECH CO LTD.
Manufacturer AddressKS


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2014-01-14

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