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..
Report Number | 9612812-2019-00001 |
MDR Report Key | 8742091 |
Report Source | DISTRIBUTOR,HEALTH PROFESSION |
Date Received | 2019-06-27 |
Date of Report | 2019-06-05 |
Date of Event | 2019-06-05 |
Date Mfgr Received | 2019-06-05 |
Device Manufacturer Date | 2019-01-25 |
Date Added to Maude | 2019-06-27 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. SHUNSUKE KOBAYASHI |
Manufacturer Street | 461 FIFTH AVENUE, 9TH FLOOR |
Manufacturer City | NEW YORK NY 10017 |
Manufacturer Country | US |
Manufacturer Postal | 10017 |
Manufacturer Phone | 2126978150 |
Manufacturer G1 | TORAY INDUSTRIES. INC. SETA PLANT |
Manufacturer Street | 1-1, OE 1-CHOME |
Manufacturer City | OTSU, SHIGA, 520-2141 |
Manufacturer Country | JA |
Manufacturer Postal Code | 520-2141 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | INOUE BALLOON CATHETER |
Generic Name | CATHETER, PERCUTANEOUS (VALVULOPLASTY) |
Product Code | MAD |
Date Received | 2019-06-27 |
Returned To Mfg | 2019-06-14 |
Catalog Number | PTMC-28 |
Lot Number | 190124 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TORAY INDUSTRIES, INC. |
Manufacturer Address | 1-1, NIHONBASHI-MUROMACHI 2-CHOME CHUO-KU, TOKYO, 103-8666 JA 103-8666 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2019-06-27 |