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 |