MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-23 for NUCLEUS HYBRID L24 CI24RE (L24) NA manufactured by Cochlear Ltd.
[97943137]
This report is submitted january 23, 2018.
Patient Sequence No: 1, Text Type: N, H10
[97943138]
It was reported that the patient experienced necrosis at the implant site in (b)(6) 2017 and subsequently was treated with a topical steroid (duration not reported).
Patient Sequence No: 1, Text Type: D, B5
Report Number | 6000034-2018-00191 |
MDR Report Key | 7211563 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2018-01-23 |
Date of Report | 2018-01-12 |
Date Mfgr Received | 2018-01-12 |
Device Manufacturer Date | 2011-03-08 |
Date Added to Maude | 2018-01-23 |
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 |
Reporter Occupation | AUDIOLOGIST |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MRS. SUJEEWA WIJESINGHE |
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 | NUCLEUS HYBRID L24 |
Generic Name | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Product Code | PGQ |
Date Received | 2018-01-23 |
Model Number | CI24RE (L24) |
Catalog Number | NA |
Lot Number | NA |
Device Expiration Date | 2013-03-07 |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | N |
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 | 2018-01-23 |