MASK SURGICAL FOG FREE FOAM AT74535

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-27 for MASK SURGICAL FOG FREE FOAM AT74535 manufactured by Quiroproductos De Cuauhtemoc S. De R.l. De C.v..

MAUDE Entry Details

Report Number1423537-2020-00398
MDR Report Key9632161
Date Received2020-01-27
Date of Report2020-01-27
Date of Event2019-12-19
Date Mfgr Received2020-01-02
Date Added to Maude2020-01-27
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 ContactPATRICIA TUCKER
Manufacturer Street3651 BIRCHWOOD DRIVE
Manufacturer CityWAUKEGAN IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8478874151
Manufacturer G1QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.
Manufacturer StreetAVE. RIO STA. CLARA - LOTES 12
Manufacturer CityCUAUHTEMOC, CHIHUAHUA 31543
Manufacturer CountryMX
Manufacturer Postal Code31543
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMASK SURGICAL FOG FREE FOAM
Generic NameMASK, SURGICAL
Product CodeFXX
Date Received2020-01-27
Model NumberAT74535
Catalog NumberAT74535
Lot Number19FLH293
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerQUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.
Manufacturer AddressAVE. RIO STA. CLARA - LOTES 12 CUAUHTEMOC, CHIHUAHUA 31543 MX 31543


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-27

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