MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-08 for NUCLEUS HYBRID L24 CI24RE (L24) N/A manufactured by Cochlear Ltd.
[141304584]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141304585]
Per the clinic, the patient experienced infection at implant site and was treated with oral and iv antibiotics, following treatment the patient was placed under general anaesthetic to undergo skin revision surgery. The implanted device remains.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2019-00497 |
| MDR Report Key | 8494228 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-08 |
| Date of Report | 2019-07-05 |
| Date Mfgr Received | 2019-07-05 |
| Device Manufacturer Date | 2018-01-09 |
| Date Added to Maude | 2019-04-08 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEUS HYBRID L24 |
| Generic Name | NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM |
| Product Code | PGQ |
| Date Received | 2019-04-08 |
| Returned To Mfg | 2019-06-24 |
| Model Number | CI24RE (L24) |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-08 |