COM-FIT SUPER SENSITIVE EAR LOOP WHITE 20346

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-09-20 for COM-FIT SUPER SENSITIVE EAR LOOP WHITE 20346 manufactured by Dentsply Llc.

MAUDE Entry Details

Report Number2424472-2019-00146
MDR Report Key9097300
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-09-20
Date of Report2019-09-20
Date Mfgr Received2019-08-21
Date Added to Maude2019-09-20
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 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494424
Manufacturer G1PRESTIGE AMERITECH
Manufacturer Street7201 IRON HORSE BLVD.
Manufacturer CityNORTH RICHLAND HILLS TX 76180
Manufacturer CountryUS
Manufacturer Postal Code76180
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOM-FIT SUPER SENSITIVE EAR LOOP WHITE
Generic NameMASK, SURGICAL
Product CodeFXX
Date Received2019-09-20
Model NumberNA
Catalog Number20346
Lot NumberD687203461
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY LLC
Manufacturer Address1301 SMILE WAY YORK PA 17404 US 17404


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-09-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.