1392 5.9MM STRYKER SHEATH 2 WAY -NS 281392

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2019-09-13 for 1392 5.9MM STRYKER SHEATH 2 WAY -NS 281392 manufactured by Depuy Mitek Llc Us.

MAUDE Entry Details

Report Number1221934-2019-58300
MDR Report Key9036206
Report SourceCOMPANY REPRESENTATIVE,OTHER
Date Received2019-09-13
Date of Report2018-02-23
Date of Event2018-02-23
Date Mfgr Received2018-02-23
Date Added to Maude2019-09-13
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 ContactKARA DITTY-BOVARD
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6013142063
Manufacturer G1DEPUY MITEK LLC US
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal Code02767
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name1392 5.9MM STRYKER SHEATH 2 WAY -NS
Generic NameRIGID ENDOSCOPE SHEATH
Product CodeHNX
Date Received2019-09-13
Catalog Number281392
Lot Number61918014
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY MITEK LLC US
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-13

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