CT-SPOT 118

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-07-19 for CT-SPOT 118 manufactured by Beekley Corporation.

MAUDE Entry Details

Report Number9021987-2019-00002
MDR Report Key8808172
Report SourceHEALTH PROFESSIONAL
Date Received2019-07-19
Date of Report2019-07-19
Date of Event2019-07-11
Date Mfgr Received2019-07-11
Date Added to Maude2019-07-19
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 FDA3
Event Location3
Manufacturer ContactKATE CHASE
Manufacturer Street1 PRESTIGE LANE
Manufacturer CityBRISTOL CT 06010
Manufacturer CountryUS
Manufacturer Postal06010
Manufacturer Phone8605834700
Manufacturer G1BEEKLEY CORPORATION
Manufacturer Street1 PRESTIGE LANE
Manufacturer CityBRISTOL CT 06010
Manufacturer CountryUS
Manufacturer Postal Code06010
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCT-SPOT
Generic NameCT SIMULATION SKIN MARKERS
Product CodeJAC
Date Received2019-07-19
Model Number118
Catalog Number118
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBEEKLEY CORPORATION
Manufacturer Address1 PRESTIGE LANE BRISTOL CT 06010 US 06010


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-19

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