MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-01 for ASKU manufactured by Cochlear Ltd.
[131761500]
Device details were not made available at the time of this report. This report is submitted on january 2, 2019, by cochlear limited on behalf of cochlear americas. Exemption number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131761501]
Per the surgeon, the patient experienced a loss of osseointegration resulting in fixture loss. The patient is being clinically managed by the health care provider. Additional information has been requested but has not been made available as of the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2018-02534 |
| MDR Report Key | 8207432 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-01 |
| Date of Report | 2018-12-06 |
| Date Mfgr Received | 2018-12-06 |
| Date Added to Maude | 2019-01-01 |
| 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. TAMARA MARTIN |
| Manufacturer Street | 1 UNIVERSITY AVENUE |
| Manufacturer City | MACQUARIE UNIVERSITY, NSW 2109 |
| Manufacturer Country | AS |
| Manufacturer Postal | 2109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASKU |
| Generic Name | COCHLEAR BAHA VISTAFIX SYSTEM |
| Product Code | FZE |
| Date Received | 2019-01-01 |
| Model Number | ASKU |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COCHLEAR LTD |
| Manufacturer Address | 1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, NSW 2109 AS 2109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-01 |