BALLOON MAJ-1351

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-08-23 for BALLOON MAJ-1351 manufactured by Olympus Medical Systems Corp..

MAUDE Entry Details

Report Number8010047-2019-03026
MDR Report Key8928621
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-08-23
Date of Report2019-08-23
Date of Event2019-07-22
Date Mfgr Received2019-07-25
Date Added to Maude2019-08-23
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 KAZUTAKA MATSUMOTO
Manufacturer Street2951 ISHIKAWA-CHO
Manufacturer CityHACHIOJI-SHI, TOKYO-TO 192-8507
Manufacturer CountryJA
Manufacturer Postal192-8507
Manufacturer Phone426425177
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBALLOON
Generic NameBALLOON
Product CodePSV
Date Received2019-08-23
Model NumberMAJ-1351
Lot Number91K
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer Address2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-23

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