FDA Adverse Event
Other
Summary report: N
SWAN NECK COIL CATH CA2 LEFT
MDR report key: 2753787
·
Received September 14, 2012
Report
- Report Number
- 1317749-2012-00209
- 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: 09/14/2012.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS CATHETER. THE CUSTOMER STATES THE PERITONEAL CATHETER WAS IMPLANTED ON (B)(6) 2012. THE CATHETER MIGRATED AND WAS ENTANGLED IN THE FALLOPIAN TUBES. A LAPAROSCOPIC PROCEDURE WAS COMPLETED ON (B)(6) 2012 TO CORRECT THE LOCATION OF THE MIGRATED CATHETER. PERITONEAL DIALYSIS TREATMENT HAS CONTINUED.
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 |