PEN NEEDLES FG PNDL, 3BV TVH TP 31G 8MM100CT 30/CS S5H01D31-100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-24 for PEN NEEDLES FG PNDL, 3BV TVH TP 31G 8MM100CT 30/CS S5H01D31-100 manufactured by Trividia Health Inc.

MAUDE Entry Details

Report Number1000113657-2020-00180
MDR Report Key9871408
Report SourceCONSUMER
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-02-27
Date Facility Aware2020-02-27
Date Mfgr Received2020-02-27
Date Added to Maude2020-03-24
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 ContactKAREN DEVINCENT
Manufacturer Street2400 NW 55TH COURT
Manufacturer CityFORT LAUDERDALE FL 33309
Manufacturer CountryUS
Manufacturer Postal33309
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePEN NEEDLES FG
Generic NameHYPODERMIC SINGLE LUMEN NEEDLE
Product CodeFMI
Date Received2020-03-24
Model NumberPNDL, 3BV TVH TP 31G 8MM100CT 30/CS
Catalog NumberS5H01D31-100
Lot NumberY46ZK2
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTRIVIDIA HEALTH INC
Manufacturer Address2400 NW 55TH COURT FORT LAUDERDALE FL 33309 US 33309


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

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