FDA Adverse Event
Injury
Summary report: N
COCHLEAR OSIA OSI300 IMPLANT
MDR report key: 19306911
·
Received May 13, 2024
Report
- Report Number
- 6000034-2024-01712
- Event Type
- Injury
- Date Received
- May 13, 2024
- Report Date
- May 17, 2024
- Manufacturer
- COCHLEAR LIMITED
- Product Code
- MCM
- UDI-DI
- 09321502070676
- PMA / PMN Number
- K231204
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON MAY 14, 2024.
Additional Manufacturer Narrative · 0
DEVICE ANALYSIS REPORT ATTACHED. THIS REPORT IS SUBMITTED ON JUNE 14, 2024.
Description of Event or Problem · 0
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AND WAS TREATED WITH TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THE DEVICE WAS EXPLANTED ON (B)(6) 2024. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189106 | COCHLEAR OSIA OSI300 IMPLANT | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LIMITED | OSI300 | NA | 09321502070676 |
| 598789 | COCHLEAR OSIA OSI300 IMPLANT | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LIMITED | OSI300 | NA | 09321502070676 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |