MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-21 for OSI 100 IMPLANT NA manufactured by Cochlear Ltd.
| Report Number | 6000034-2019-02058 |
| MDR Report Key | 9215869 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-10-21 |
| Date of Report | 2019-10-23 |
| Date Facility Aware | 2019-09-27 |
| Date Mfgr Received | 2019-10-23 |
| Device Manufacturer Date | 2018-09-10 |
| Date Added to Maude | 2019-10-21 |
| 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 | MS. KRISTEL KOHNE |
| Manufacturer Street | 1 UNIVERSITY AVENUE |
| Manufacturer City | MACQAURIE UNIVERSITY, NSW 2109 |
| Manufacturer Country | AS |
| Manufacturer Postal | 2109 |
| Manufacturer G1 | COCHLEAR BONE ANCHORED SOLUTIONS AB |
| Manufacturer Street | KONSTRUKTIONSV PO BOX 82 |
| Manufacturer City | M 43533 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 43533 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSI 100 IMPLANT |
| Generic Name | COCHLEAR OSIA OSI100 IMPLANT |
| Product Code | PFO |
| Date Received | 2019-10-21 |
| Model Number | OSI 100 |
| Catalog Number | NA |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COCHLEAR LTD |
| Manufacturer Address | 1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, 2109 AS 2109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-21 |