FLOQSWAB 503CS01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-12 for FLOQSWAB 503CS01 manufactured by Copan Flock Technologies Srl.

MAUDE Entry Details

Report Number3005477219-2019-00004
MDR Report Key8691282
Date Received2019-06-12
Date of Report2019-05-14
Date of Event2019-04-25
Date Mfgr Received2019-05-14
Date Added to Maude2019-06-12
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 ContactMS STEFANIA TRIVA
Manufacturer StreetVIA F. PEROTTI 16-18
Manufacturer CityBRESCIA, ITALY 25125
Manufacturer CountryIT
Manufacturer Postal25125
Manufacturer G1COPAN FLOCK TECHNOLOGIES SRL
Manufacturer StreetVIA F. PEROTTI 16-18
Manufacturer CityBRESCIA,
Manufacturer CountryIT
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameFLOQSWAB
Generic NameAPPLICATOR, ABORBENT TIPPED, STERILE, PRODUCT CODE: KXG
Product CodeKXG
Date Received2019-06-12
Model Number503CS01
Catalog Number503CS01
Lot Number1814374
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOPAN FLOCK TECHNOLOGIES SRL
Manufacturer AddressVIA F. PEROTTI 16-18 BRESCIA, 25125 IT 25125


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-06-12

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