MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-26 for ASKU manufactured by Cochlear Ltd.
[112407266]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[112407267]
Per the clinic, the patient developed chronic cellulitis and an infection at the abutment site. Additional information has been requested but has not been made available as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
[114595561]
It was reported that the device was explanted on (b)(6) 2018 under a general anaesthetic.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000034-2018-01315 |
| MDR Report Key | 7639768 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-25 |
| Date of Event | 2018-06-15 |
| Date Mfgr Received | 2018-06-25 |
| Date Added to Maude | 2018-06-26 |
| 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. SUJEEWA WIJESINGHE |
| 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 | ASKU |
| Generic Name | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
| Product Code | FZE |
| Date Received | 2018-06-26 |
| Model Number | ASKU |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2018-06-26 |