INOUE BALLOON CATHETER PTMC-28

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-06-27 for INOUE BALLOON CATHETER PTMC-28 manufactured by Toray Industries, Inc..

MAUDE Entry Details

Report Number9612812-2019-00001
MDR Report Key8742091
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2019-06-27
Date of Report2019-06-05
Date of Event2019-06-05
Date Mfgr Received2019-06-05
Device Manufacturer Date2019-01-25
Date Added to Maude2019-06-27
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. SHUNSUKE KOBAYASHI
Manufacturer Street461 FIFTH AVENUE, 9TH FLOOR
Manufacturer CityNEW YORK NY 10017
Manufacturer CountryUS
Manufacturer Postal10017
Manufacturer Phone2126978150
Manufacturer G1TORAY INDUSTRIES. INC. SETA PLANT
Manufacturer Street1-1, OE 1-CHOME
Manufacturer CityOTSU, SHIGA, 520-2141
Manufacturer CountryJA
Manufacturer Postal Code520-2141
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINOUE BALLOON CATHETER
Generic NameCATHETER, PERCUTANEOUS (VALVULOPLASTY)
Product CodeMAD
Date Received2019-06-27
Returned To Mfg2019-06-14
Catalog NumberPTMC-28
Lot Number190124
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTORAY INDUSTRIES, INC.
Manufacturer Address1-1, NIHONBASHI-MUROMACHI 2-CHOME CHUO-KU, TOKYO, 103-8666 JA 103-8666


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 2019-06-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.