AIA-900 022930111

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for AIA-900 022930111 manufactured by Tosoh Corporation.

MAUDE Entry Details

Report Number8031673-2020-00088
MDR Report Key9908379
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-02
Date Mfgr Received2020-03-02
Device Manufacturer Date2018-05-01
Date Added to Maude2020-03-31
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 ContactMS. BERNADETTE OCONNELL
Manufacturer StreetSHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA
Manufacturer CityMINATO-KU, TOKYO 1058623
Manufacturer CountryJA
Manufacturer Postal1058623
Manufacturer G1TOSOH CORPORATION
Manufacturer StreetSHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA
Manufacturer CityMINATO-KU, 1058623
Manufacturer CountryJA
Manufacturer Postal Code1058623
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAIA-900
Generic NameAIA-900
Product CodeKHO
Date Received2020-03-31
Model NumberAIA-900
Catalog Number022930111
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTOSOH CORPORATION
Manufacturer AddressSHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA MINATO-KU, 1058623 JA 1058623


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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