FDA Adverse Event
Other
Summary report: N
ON-Q C-BLOC
MDR report key: 1220251
·
Received October 31, 2008
Report
- Report Number
- 2026095-2008-00176
- Event Type
- Other
- Date Received
- October 31, 2008
- Date of Event
- September 20, 2008
- Report Date
- September 29, 2008
- Manufacturer
- I-FLOW CORP.
- Product Code
- MEB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. NO SAMPLE WAS AVAILABLE FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT OR LOT #, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. THE LOT AND DEVICE HISTORY RECORDS CANNOT BE REVIEWED WITHOUT A LOT #. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE INITIAL REPORTER, BUT HAS NOT YET BEEN RECEIVED. THIS COMPLAINT IS UNDER INVESTIGATION.
Description of Event or Problem · 1
PT WAS REPORTED TO HAVING HAD A SEIZURE DESCRIBED AS FOAMING AND DROOLING AT THE MOUTH. THE PT WAS ADMITTED INTO THE HOSP AND DISCHARGED THE FOLLOWING DAY. PEDIATRIC DOCTOR SUGGESTED THAT THE SEIZURE WAS A ROLANDIC TYPE, AND MAY HAVE BEEN SET OFF BY THE LIDOCAINE. FILL VOLUME 400ML, FLOW RATE 4ML/HR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ON-Q C-BLOC | INFUSION PUMP | MEB | I-FLOW CORP. | CB004 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention |