COM-FIT? PLUSH MASKS CFP-3 0020354FG

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 2020-02-12 for COM-FIT? PLUSH MASKS CFP-3 0020354FG manufactured by Dentsply Llc.

MAUDE Entry Details

Report Number2424472-2019-00213
MDR Report Key9702013
Report SourceHEALTH PROFESSIONAL
Date Received2020-02-12
Date of Report2020-02-28
Date Mfgr Received2019-11-26
Date Added to Maude2020-02-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. KARL NITTINGER
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK, PA
Manufacturer CountryUS
Manufacturer Phone8494424
Manufacturer G1PRESTIGE AMERITECH
Manufacturer Street7201 IRON HORSE BLVD.
Manufacturer CityNORTH RICHLAND HILLS, TX
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOM-FIT? PLUSH MASKS CFP-3
Generic NameMASK, SURGICAL
Product CodeFXX
Date Received2020-02-12
Returned To Mfg2019-12-09
Model NumberNA
Catalog Number0020354FG
Lot Number19060254
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY LLC
Manufacturer Address1301 SMILE WAY YORK, PA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-12

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