MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-06-10 for NUCLEUS 24 ABI ABI24M NA manufactured by Cochlear Ltd.
Report Number | 6000034-2019-00944 |
MDR Report Key | 8685336 |
Report Source | COMPANY REPRESENTATIVE |
Date Received | 2019-06-10 |
Date of Report | 2019-09-06 |
Date Mfgr Received | 2019-09-06 |
Date Added to Maude | 2019-06-10 |
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 | MRS BIANCA PRIES |
Manufacturer Street | 1 UNIVERSITY AVENUE |
Manufacturer City | MACQAURIE 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 | NUCLEUS 24 ABI |
Generic Name | NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM |
Product Code | MHE |
Date Received | 2019-06-10 |
Returned To Mfg | 2019-07-24 |
Model Number | ABI24M |
Catalog Number | NA |
Lot Number | NA |
Operator | LAY USER/PATIENT |
Device Availability | R |
Device Age | DA |
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 | 2019-06-10 |