ADHERUS AUTOSPRAY ET DURAL SEALANT NUS-109

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-29 for ADHERUS AUTOSPRAY ET DURAL SEALANT NUS-109 manufactured by Stryker Corp. (hyperbranch Medical Technology, Inc.).

MAUDE Entry Details

Report Number9391764
MDR Report Key9391764
Date Received2019-11-29
Date of Report2019-11-21
Date of Event2019-11-20
Report Date2019-11-21
Date Reported to FDA2019-11-21
Date Reported to Mfgr2019-11-29
Date Added to Maude2019-11-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADHERUS AUTOSPRAY ET DURAL SEALANT
Generic NameSEALANT, DURAL
Product CodeNQR
Date Received2019-11-29
Model NumberNUS-109
Lot Number05192724
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER CORP. (HYPERBRANCH MEDICAL TECHNOLOGY, INC.)
Manufacturer Address800 CAPITOLA DR STE 12 DURHAM NC 27713 US 27713


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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