REN? TRANSORAL NEEDLE 12-000-00-ND1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-26 for REN? TRANSORAL NEEDLE 12-000-00-ND1 manufactured by Cytophil, Inc..

MAUDE Entry Details

Report Number3007225376-2019-00006
MDR Report Key9377700
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-11-26
Date of Report2019-11-26
Date of Event2019-10-25
Date Mfgr Received2019-10-30
Device Manufacturer Date2019-04-23
Date Added to Maude2019-11-26
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 ContactMRS. KRISTIE SOTO
Manufacturer Street2485 CORPORATE CIRCLE SUITE 2
Manufacturer CityEAST TROY WI 53120
Manufacturer CountryUS
Manufacturer Postal53120
Manufacturer Phone2626422765
Manufacturer G1CYTOPHIL, INC.
Manufacturer Street2485 CORPORATE CIRCLE SUITE 2
Manufacturer CityEAST TROY WI 53120
Manufacturer CountryUS
Manufacturer Postal Code53120
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREN? TRANSORAL NEEDLE
Generic NameNEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
Product CodeGAA
Date Received2019-11-26
Returned To Mfg2019-11-25
Model Number12-000-00-ND1
Catalog Number12-000-00-ND1
Lot NumberQ912-00031
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCYTOPHIL, INC.
Manufacturer Address2485 CORPORATE CIRCLE SUITE 2 EAST TROY WI 53120 US 53120


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-26

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