FDA Adverse Event
Summary report: N
QUINTON PERITONEAL DIALYSIS CATHETER
MDR report key: 517468
·
Received March 24, 2004
Report
- Report Number
- 1317749-2004-00021
- Date Received
- March 24, 2004
- Date of Event
- February 18, 2004
- Report Date
- March 23, 2004
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- FKO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD A PROBLEM WITH A PERITONEAL DIALYSIS CATHETER. THE CUSTOMER REPORTS, "A PT STARTED PD RECENTLY, AND PT EXPERIENCED AN ALLERGIC REACTION. SIXTEEN DAYS AFTER THE START OF DIALYSIS, CLOUDY EFFLUENT WAS NOTED. THIS REACTION WAS OBSERVED THROUGH EFFLUENT LAB DATA, THERE WAS AN INCREASE IN LEUKOCYTES, THERE WAS A MAJOR QUANTITY OF EOSINOPHIL CELLS, MACROPHAGE CELLS AND MESOTELLIALE CELLS. THERE WER NO CLINICAL SYMPTOMS, NO FEVER, NO PAIN, NO INFLAMMATORY SYNDROME. DIALYSIS STOPPED AND CATHETER REMOVED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUINTON PERITONEAL DIALYSIS CATHETER | PERITONEAL DIALYSIS CATHETER | FKO | TYCO HEALTHCARE/KENDALL | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |