FDA Adverse Event
Injury
Summary report: N
FINESSE PRIMO
MDR report key: 3051531
·
Received April 10, 2013
Report
- Report Number
- 6000095-2013-00011
- Event Type
- Injury
- Date Received
- April 10, 2013
- Date of Event
- February 4, 2003
- Report Date
- January 22, 2013
- Manufacturer
- VITATRON MEDICAL B.V.
- Product Code
- DXY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
EROSION OF THE DEVICE WAS REPORTED. A NEW DEVICE WAS IMPLANTED AND MOVED TO THE "OTHER SIDE." NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148909 | FINESSE PRIMO | DXY | VITATRON MEDICAL B.V. | 205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |