MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-08-23 for BALLOON MAJ-1351 manufactured by Olympus Medical Systems Corp..
Report Number | 8010047-2019-03026 |
MDR Report Key | 8928621 |
Report Source | COMPANY REPRESENTATIVE,USER F |
Date Received | 2019-08-23 |
Date of Report | 2019-08-23 |
Date of Event | 2019-07-22 |
Date Mfgr Received | 2019-07-25 |
Date Added to Maude | 2019-08-23 |
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 KAZUTAKA MATSUMOTO |
Manufacturer Street | 2951 ISHIKAWA-CHO |
Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
Manufacturer Country | JA |
Manufacturer Postal | 192-8507 |
Manufacturer Phone | 426425177 |
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 | 2019-08-23 |
Model Number | MAJ-1351 |
Lot Number | 91K |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
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 | 2019-08-23 |