FDA Adverse Event
Malfunction
Summary report: N
OLM INTRACRANIAL PRESSURE MONITORING KIT
MDR report key: 1963673
·
Received December 21, 2010
Report
- Report Number
- 2023988-2010-00047
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Report Date
- December 21, 2010
- Manufacturer
- INTEGRA NEUROSCIENCES SD
- Product Code
- GWM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
A 1104B CAMINO INTRACRANIAL PRESSURE MONITORING KIT WAS INVOLVED IN AN INCIDENT AND WAS DESCRIBED AS FOLLOWS; A PART OF THE DEVICE (PART NOT SPECIFIED) LOOSENED DURING SURGERY. THE PRODUCT WAS IN CONTACT WITH THE PATIENT, BUT THERE IS NO INFORMATION ABOUT WHETHER THE PATIENT WAS INJURED OR WHETHER THERE WAS A DELAY OF SURGERY TIME. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLM INTRACRANIAL PRESSURE MONITORING KIT | N/A | GWM | INTEGRA NEUROSCIENCES SD | 30100178643 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |