ADHERUS AUTOSPRAY NUS-106

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-07-31 for ADHERUS AUTOSPRAY NUS-106 manufactured by Stryker Cmf Us.

MAUDE Entry Details

Report Number3005920920-2019-00003
MDR Report Key8845653
Report SourceDISTRIBUTOR
Date Received2019-07-31
Date of Report2019-07-31
Date of Event2018-01-09
Date Mfgr Received2018-04-16
Date Added to Maude2019-07-31
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 ContactMR. KELLI DYKSTRA
Manufacturer StreetBOETZINGERSTR. 41
Manufacturer CityFREIBURG D-79111
Manufacturer PostalD-79111
Manufacturer Phone76145120
Manufacturer G1STRYKER CMF US
Manufacturer StreetMICRO IMPLANTS 750 TRADE CENTRE WAY SUITE 200
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal Code49002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADHERUS AUTOSPRAY
Generic NameNQR
Product CodeGXP
Date Received2019-07-31
Catalog NumberNUS-106
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER CMF US
Manufacturer AddressMICRO IMPLANTS 750 TRADE CENTRE WAY SUITE 200 PORTAGE MI 49002 US 49002


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-31

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