FDA Adverse Event
Malfunction
Summary report: N
CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT,
MDR report key: 5355428
·
Received January 8, 2016
Report
- Report Number
- 3006697299-2016-00004
- Event Type
- Malfunction
- Date Received
- January 8, 2016
- Report Date
- January 5, 2016
- Manufacturer
- INTEGRA NEUROSCIENCES, LTD
- Product Code
- GWM
- PMA / PMN Number
- K962928
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RETROSPECTIVE REVIEW OF COMPLAINT INDICATES CORRECTION MDR IS NEEDED. INITIAL MDR FILED WITH INCORRECT ESTABLISHMENT REGISTRATION NUMBER (8010219-2015-00003).
Description of Event or Problem · 1
RETROSPECTIVE REVIEW OF COMPLAINT INDICATES CORRECTION MDR IS NEEDED. INITIAL MDR FILED WITH INCORRECT ESTABLISHMENT REGISTRATION NUMBER (8010219-2015-00003).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 13994 | CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT, | N/A | GWM | INTEGRA NEUROSCIENCES, LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |