MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-18 for * manufactured by Kendall Healthcare.
[221620]
Capd catheter was defective and had to be surgically removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021658 |
| MDR Report Key | 327813 |
| Date Received | 2001-04-18 |
| Date of Report | 2001-04-09 |
| Date of Event | 2001-04-04 |
| Date Added to Maude | 2001-04-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | C.A.P.D. CATHETER |
| Product Code | FKO |
| Date Received | 2001-04-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 317205 |
| Manufacturer | KENDALL HEALTHCARE |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-04-18 |