NOXBOXI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,health p report with the FDA on 2020-02-20 for NOXBOXI manufactured by Noxbox, Ltd.

MAUDE Entry Details

Report Number3012796317-2020-00001
MDR Report Key9732356
Report SourceCONSUMER,DISTRIBUTOR,HEALTH P
Date Received2020-02-20
Date of Report2020-02-17
Date of Event2020-01-15
Date Mfgr Received2020-01-16
Date Added to Maude2020-02-20
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 ContactKAREN RING
Manufacturer Street1081 GALLEY DRIVE KENT SCIENCE PARK
Manufacturer CitySITTINGBOURNE, KENT ME9 8GA
Manufacturer CountryUK
Manufacturer PostalME9 8GA
Manufacturer G1NOXBOX, LTD
Manufacturer Street1081 GALLEY DRIVE KENT SCIENCE PARK
Manufacturer CitySITTINGBOURNE, KENT ME9 8GA
Manufacturer CountryUK
Manufacturer Postal CodeME9 8GA
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNOXBOXI
Generic NameNITRIC OXIDE ADMINISTRATION APPARATUS
Product CodeMRN
Date Received2020-02-20
Returned To Mfg2020-02-13
Model NumberNOXBOXI
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNOXBOX, LTD
Manufacturer Address1081 GALLEY DRIVE KENT SCIENCE PARK SITTINGBOURNE, KENT ME9 8GA UK ME9 8GA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-20

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