FDA Adverse Event
Summary report: N
INTRACRANIAL PRESSURE MONITORING KIT 110-4BT
MDR report key: 541595
·
Received March 31, 2004
Report
- Report Number
- 2023988-2004-00033
- Date Received
- March 31, 2004
- Report Date
- March 30, 2004
- Manufacturer
- INTEGRA NEUROCARE LLC
- Product Code
- GWM
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
TWO RETURNS WERE REC'D WITH TWO DIFFERENT LOT NUMBERS, THEREFORE THE SECOND CATHETER WAS DOCUMENTED AS BEING RECEIVED. THE DISTRIBUTOR REPORTS THE SURGEON PAID ATTENTION NOT TO BEND THE CATHETER DURING INSERTION. JUST AFTER INSERTING THE CATHETER IN THE PT, ADEQUATE VALUES WERE DISPLAYED. HOWEVER, LATER IN THE DAY THE MONITOR DISPLAYED "CHECK CATHETER." THE ADEQUATE INTRACRANIAL PRESSURE WAS DISPLAYED ON THE FIRST DAY OF USE BUT THE TEMPERATURE WAS NOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTRACRANIAL PRESSURE MONITORING KIT 110-4BT | NEURO MONITORING | GWM | INTEGRA NEUROCARE LLC | * | W043015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |