MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for COCHLEAR OSIA OS2100 IMPLANT OSI100 NA manufactured by Cochlear Ltd.
[177537224]
This report is submitted on february 4, 2020.
Patient Sequence No: 1, Text Type: N, H10
[177537225]
Per the clinic, the patient experienced an infection at the implant site. The patient was hospitalised on (b)(6) 2020 and iv antibiotics were administered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00235 |
| MDR Report Key | 9663205 |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-10 |
| Report Date | 2020-02-04 |
| Date Reported to FDA | 2020-02-04 |
| Date Reported to Mfgr | 2020-01-10 |
| Date Added to Maude | 2020-02-04 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COCHLEAR OSIA OS2100 IMPLANT |
| Generic Name | COCHLEAR? OSIA? SYSTEM |
| Product Code | PFO |
| Date Received | 2020-02-04 |
| Model Number | OSI100 |
| Catalog Number | NA |
| Lot Number | NA |
| Device Expiration Date | 2019-12-12 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COCHLEAR LTD |
| Manufacturer Address | 1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, 2109 AS 2109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-04 |