MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2004-03-24 for QUINTON PERITONEAL DIALYSIS CATHETER * UNK DY manufactured by Tyco Healthcare/kendall.
[353828]
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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317749-2004-00021 |
| MDR Report Key | 517468 |
| Report Source | 05,07 |
| Date Received | 2004-03-24 |
| Date of Report | 2004-03-23 |
| Date of Event | 2004-02-18 |
| Report Date | 2004-03-23 |
| Date Mfgr Received | 2004-03-16 |
| Date Added to Maude | 2004-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NOREEN FEWER |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618441 |
| Manufacturer G1 | TYCO HEALTHCARE/KENDALL |
| Manufacturer Street | RTE 40 |
| Manufacturer City | ARGYLE NY 12809 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12809 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUINTON PERITONEAL DIALYSIS CATHETER |
| Generic Name | PERITONEAL DIALYSIS CATHETER |
| Product Code | FKO |
| Date Received | 2004-03-24 |
| Model Number | * |
| Catalog Number | UNK DY |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 506505 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US |
| Baseline Brand Name | DIALYSIS UNKNOWN |
| Baseline Generic Name | DIALYSIS CATHETER |
| Baseline Model No | * |
| Baseline Catalog No | UNK DY |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-03-24 |