FDA Adverse Event
Other
Summary report: N
ON-Q C-BLOC
MDR report key: 1023724
·
Received March 28, 2008
Report
- Report Number
- 2026095-2008-00028
- Event Type
- Other
- Date Received
- March 28, 2008
- Date of Event
- February 29, 2008
- Report Date
- February 29, 2008
- Manufacturer
- I-FLOW CORP.
- Product Code
- MEB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE ACTUAL PART NUMBER, LOT NUMBER, AND ACTUAL PRODUCT WERE NOT AVAILABLE FOR THIS INVESTIGATION. FROM THE DESCRIPTION OF THE INCIDENT, ANESTHETIC TOXICITY OR AN ALLERGIC REACTION TO THE MEDICATION MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. FOLLOWING DOCTOR'S INSTRUCTIONS, THE PUMP WAS CONTINUED UNTIL EMPTY, BUT AT A LOW INFUSION RATE OF 2ML/HR. PT WAS DOING WELL UPON FOLLOW-UP. NO MALFUNCTION OF THE PUMP WAS REPORTED. IF ADDITIONAL INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.
Description of Event or Problem · 1
PT'S LEFT EYE WAS SWOLLEN, MOUTH DROOPING AND TIGHTNESS IN CHEST.
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 | Required Intervention |