FDA Adverse Event
Injury
Summary report: N
CP1150 MAGNET (STRENGTH 4 (I))
MDR report key: 14784708
·
Received June 23, 2022
Report
- Report Number
- 6000034-2022-01818
- Event Type
- Injury
- Date Received
- June 23, 2022
- Date of Event
- January 4, 2022
- Report Date
- June 1, 2022
- Manufacturer
- COCHLEAR LIMITED
- Product Code
- MCM
- UDI-DI
- 09321502036573
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON JUNE 23, 2022
Additional Manufacturer Narrative · 0
CORRECTION: THE DEVICE DETAILS SUBMITTED IN THE PREVIOUS REPORT ON JUNE 23, 2022, WERE INCORRECT. THE DETAILS FOR SECTION D HAVE BEEN UPDATED ACCORDINGLY. THIS REPORT IS SUBMITTED ON JULY 26, 2022.
Description of Event or Problem · 0
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND THE BUILD-UP OF FLUID (EFFUSION) AND AN INFECTION AT THE IMPLANT SITE WHICH WAS TREATED WITH A TOPICAL ANTIBIOTIC. THE IMPLANT REMAINS IN-SITU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331670 | CP1150 MAGNET (STRENGTH 4 (I)) | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LIMITED | CP1150 MAGNET | N/A | 09321502036573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Female | Required Intervention |