MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2004-04-09 for SWAN NECK COIL CATH CA2 LEFT * 8888413807 manufactured by Tyco Healthcare/kendall.
[335699]
It was reported to tyco healthcare/kendall that a customer had a problem with a peritioneal catheter. The customer reports, "the catheter had 6 small holes in the portion that remains outside of the body, causing solution to leak. Pt had fever, abdominal pain, and staph aureus. Pt received antibiotic treatment for one week with vancomycin, ceftazidime, and cipro.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317749-2004-00025 |
| MDR Report Key | 519919 |
| Report Source | 05,07 |
| Date Received | 2004-04-09 |
| Date of Report | 2004-04-08 |
| Date of Event | 2003-12-01 |
| Date Reported to Mfgr | 2004-03-26 |
| Date Added to Maude | 2004-04-12 |
| 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, RN |
| 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 | ROUTE 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 | SWAN NECK COIL CATH CA2 LEFT |
| Generic Name | PERITONEAL DIALYSIS |
| Product Code | FKS |
| Date Received | 2004-04-09 |
| Model Number | * |
| Catalog Number | 8888413807 |
| Lot Number | 136115 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 509000 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | 15 HAMPSHIRE ST. MANSFIELD MA 02048 US |
| Baseline Brand Name | SWAN NECK COIL CATH CA2 LEFT |
| Baseline Generic Name | DILAYSIS CATHETER |
| Baseline Model No | * |
| Baseline Catalog No | 8888413807 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-04-09 |