MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-02-10 for 02 086010 manufactured by C.r. Bard, Inc..
| Report Number | 1018233-2000-00003 |
| MDR Report Key | 262160 |
| Report Source | 06 |
| Date Received | 2000-02-10 |
| Date of Report | 2000-02-10 |
| Date of Event | 1999-10-21 |
| Date Mfgr Received | 2000-01-12 |
| Device Manufacturer Date | 1996-01-01 |
| Date Added to Maude | 2000-02-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VIVIAN STEPHENS |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846902 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | FEW |
| Date Received | 2000-02-10 |
| Catalog Number | 02 086010 |
| ID Number | FE6 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 253901 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US |
| Baseline Brand Name | MALECOT CATHETER |
| Baseline Generic Name | CATHETER |
| Baseline Model No | BARDEX FE6860 |
| Baseline Catalog No | 02 086010 |
| Baseline ID | FEG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-02-10 |