FDA Adverse Event
Other
Summary report: N
SWAN NECK COIL CATH CA2 LEFT
MDR report key: 2753790
·
Received September 14, 2012
Report
- Report Number
- 1317749-2012-00206
- Event Type
- Other
- Date Received
- September 14, 2012
- Date of Event
- July 13, 2012
- Report Date
- August 15, 2012
- Manufacturer
- COVIDIEN
- Product Code
- FJS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(6) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH PERITONEAL DIALYSIS CATHETER. THE CUSTOMER STATES THE PERITONEAL CATHETER WAS IMPLANTED ON (B)(6) 2012. THE CATHETER MIGRATED TO THE FLANK IN THE TRUNK OF THE UTERUS. A LAPAROSCOPIC PROCEDURE WAS COMPLETED ON (B)(6) 2012 TO CORRECT THE LOCATION OF THE MIGRATED CATHETER. THE CATHETER WAS REMOVED ON (B)(6) 2012. A NEW PD CATHETER WILL BE IMPLANTED BUT THE EXACT DATE HAS NOT YET BEEN DETERMINED. THE PATIENT HAS RECOVERED AND CONTINUES HEMODIALYSIS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWAN NECK COIL CATH CA2 LEFT | PD CATHETER | FJS | COVIDIEN | 8888413807 | 934515 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |