COMFORT COOL THUMB CMC RESTRICTION SPLINT NC79564

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 2011-08-26 for COMFORT COOL THUMB CMC RESTRICTION SPLINT NC79564 manufactured by North Coast Medical, Gilroy.

Event Text Entries

[2300904] Customer developed a rash after wearing the thumb cmc restriction splint for four days. The splint is a latex free product.
Patient Sequence No: 1, Text Type: D, B5


[9457147] Add'l catalog# nc79565.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2939821-2011-00011
MDR Report Key2249645
Report Source05
Date Received2011-08-26
Date of Report2011-08-24
Date of Event2009-01-09
Date Mfgr Received2009-01-09
Date Added to Maude2012-06-27
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 ContactDAN LYNCH
Manufacturer Street8100 CAMINO ARROYO
Manufacturer CityGILROY CA 95020
Manufacturer CountryUS
Manufacturer Postal95020
Manufacturer Phone4087765000
Manufacturer G1SCOTT SPECIALITIES INC.
Manufacturer Street512 M ST
Manufacturer CityBELLEVILLE KS 66935
Manufacturer CountryUS
Manufacturer Postal Code66935
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMFORT COOL THUMB CMC RESTRICTION SPLINT
Generic NameTHUMB CMC RESTRICTION SPLINT
Product CodeILI
Date Received2011-08-26
Model NumberNA
Catalog NumberNC79564
Lot NumberNA
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNORTH COAST MEDICAL, GILROY
Manufacturer AddressCA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-08-26

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