FDA Adverse Event
Other
Summary report: N
ON-Q PAINBUSTER KIT
MDR report key: 619562
·
Received June 30, 2005
Report
- Report Number
- 2026095-2005-00052
- Event Type
- Other
- Date Received
- June 30, 2005
- Date of Event
- May 1, 2005
- Report Date
- June 27, 2005
- Manufacturer
- I-FLOW CORP.
- Product Code
- MEB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT DEVELOPED AN ABDOMINAL INFECTION IN THE HOSPITAL SIX (6) TO SEVEN (7) DAYS POST CHEMOTHERAPY AND RADICAL MASS REDUCTION PROCEDURE. SYMPTOMS EXHIBITED WERE REDNESS AND SWELLING AT INCISION SITE.
Description of Event or Problem · 1
REPORTED ON 7/15/2005, IN 2005, CEFOTETAN, 2 GMS IV (PROPHYLACTIC ANTIBIOTIC) WAS GIVEN TO THE PT BEFORE THE OPERATION. IN 2005, THE OPERATION STARTED. THE SAME DAY, THE OPERATION FINISHED. IN 2005, CEFOTETAN 1 GM IV
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ON-Q PAINBUSTER KIT | INFUSION PUMP | MEB | I-FLOW CORP. | PM028 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |