MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-06-04 for BALLOON MAJ-1351 manufactured by Olympus Medical Systems Corp..
| Report Number | 2951238-2019-00905 |
| MDR Report Key | 8668015 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-06-04 |
| Date of Report | 2019-06-04 |
| Date of Event | 2019-05-03 |
| Date Mfgr Received | 2019-05-06 |
| Date Added to Maude | 2019-06-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLOON |
| Generic Name | BALLOON |
| Product Code | PSV |
| Date Received | 2019-06-04 |
| Returned To Mfg | 2019-05-16 |
| Model Number | MAJ-1351 |
| Lot Number | 8YK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-04 |