ARROW 260566

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 2020-02-24 for ARROW 260566 manufactured by Fh Industrie.

MAUDE Entry Details

Report Number3003898228-2020-00001
MDR Report Key9743588
Report SourceHEALTH PROFESSIONAL
Date Received2020-02-24
Date of Report2020-03-23
Date of Event2019-12-02
Date Mfgr Received2020-01-23
Device Manufacturer Date2018-10-31
Date Added to Maude2020-02-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. C HERNOUX
Manufacturer Street3 RUE DE LA FOR
Manufacturer CityHEIMSBRUNN, 68990
Manufacturer CountryFR
Manufacturer Postal68990
Manufacturer G1FH INDUSTRIE
Manufacturer Street6 RUE NOBEL
Manufacturer CityQUIMPER, 29000
Manufacturer CountryFR
Manufacturer Postal Code29000
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARROW
Generic NameGLENOSPH?RE COCR ?36
Product CodeKWT
Date Received2020-02-24
Returned To Mfg2020-01-22
Catalog Number260566
Lot NumberJ00839
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerFH INDUSTRIE
Manufacturer Address6 RUE NOBEL QUIMPER, 29000 FR 29000


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-24

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