BALLOON MAJ-1351

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-06 for BALLOON MAJ-1351 manufactured by Olympus Medical Systems Corp..

MAUDE Entry Details

Report Number8010047-2020-00807
MDR Report Key9555493
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-01-06
Date of Report2020-03-27
Date of Event2019-12-27
Date Mfgr Received2020-03-25
Device Manufacturer Date2019-05-01
Date Added to Maude2020-01-06
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 Received2020-01-06
Model NumberMAJ-1351
Lot Number95K
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2020-01-06

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