HD EPSCP,4.0,30,167,MITEK 242018

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 2020-03-26 for HD EPSCP,4.0,30,167,MITEK 242018 manufactured by Medos International Sàrl.

MAUDE Entry Details

Report Number1221934-2020-00995
MDR Report Key9886171
Report SourceCOMPANY REPRESENTATIVE,OTHER
Date Received2020-03-26
Date of Report2020-03-12
Date of Event2020-03-12
Date Mfgr Received2020-03-12
Date Added to Maude2020-03-26
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 Phone6103142063
Manufacturer G1MEDOS INTERNATIONAL SàRL
Manufacturer StreetCHEMIN-BLANC 38
Manufacturer CityLE LOCLE 02400
Manufacturer CountrySZ
Manufacturer Postal Code02400
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHD EPSCP,4.0,30,167,MITEK
Generic NameRIGID ENDOSCOPE
Product CodeHRX
Date Received2020-03-26
Model Number242018
Catalog Number242018
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDOS INTERNATIONAL SàRL
Manufacturer AddressCHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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