OVB1 CAMERA CONTROL UNIT 242300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-09-13 for OVB1 CAMERA CONTROL UNIT 242300 manufactured by Medos International Sàrl.

MAUDE Entry Details

Report Number1221934-2019-58294
MDR Report Key9033710
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-09-13
Date of Report2018-02-20
Date of Event2018-02-20
Date Mfgr Received2018-02-20
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 G1MEDOS INTERNATIONAL SARL
Manufacturer StreetCHEMIN BLANC 38
Manufacturer CityLE LOCLE CH-2400
Manufacturer CountrySZ
Manufacturer Postal CodeCH-2400
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOVB1 CAMERA CONTROL UNIT
Generic NameENDOSCOPIC VIDEO IMAGE PROCESSOR
Product CodeFWF
Date Received2019-09-13
Catalog Number242300
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2019-09-13

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