FDA Adverse Event
Malfunction
Summary report: N
ADULT CURL CATH 1CUFF
MDR report key: 1210965
·
Received June 30, 2008
Report
- Report Number
- 1317749-2008-00111
- Event Type
- Malfunction
- Date Received
- June 30, 2008
- Date of Event
- October 30, 2007
- Report Date
- June 24, 2008
- Manufacturer
- TYCO HEALTHCARE/KENALL
- Product Code
- FJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD A PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS DURING A HOME VISIT, THE PD EXIT SITE WAS EXAMINED AND WAS LEAKING. THE PD CATHETER WAS REPLACED IN 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADULT CURL CATH 1CUFF | DIALYSIS CATHETER | FJS | TYCO HEALTHCARE/KENALL | 8888411710 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |