FDA Adverse Event
Other
Summary report: N
CLOSUREFAST CATHETER, 7F, 100CM
MDR report key: 2132161
·
Received June 3, 2011
Report
- Report Number
- 2953189-2011-00029
- Event Type
- Other
- Date Received
- June 3, 2011
- Report Date
- May 13, 2011
- Manufacturer
- COVIDIEN
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A PT HAD AN ISSUE WITH A CLOSUREFAST CATHETER. THE CUSTOMER REPORTS THE PT CAME IN FOR TREATMENT ON (B)(6) 2011. DURING F/U APPOINTMENT ON (B)(6) 2011 THE PT COMPLAINED OF LEG PAIN. THE PT WAS PLACED ON PROPHYLACTIC ANTIBIOTICS FOR PRESUMED CELLULITIS. PT DID NOT GET CELLULITIS AND CUSTOMER REPORTS THE PT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLOSUREFAST CATHETER, 7F, 100CM | ELECTROSURGICAL DEVICE | GEI | COVIDIEN | CF7-7-60 | 550219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |