MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-03-31 for 3.5F BETA-RAIL DELIVERY CATHETER P02578 ABR-0346 manufactured by Novoste Corp..
| Report Number | 1062385-2005-00001 |
| MDR Report Key | 602031 |
| Report Source | 06 |
| Date Received | 2005-03-31 |
| Date of Event | 2004-09-29 |
| Date Mfgr Received | 2004-10-01 |
| Date Added to Maude | 2005-05-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MIKE SILVA |
| Manufacturer Street | 4350 INTERNATIONAL BLVD |
| Manufacturer City | NORCROSS GA 30093 |
| Manufacturer Country | US |
| Manufacturer Postal | 30093 |
| Manufacturer Phone | 7707170904 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5F BETA-RAIL DELIVERY CATHETER |
| Generic Name | CATHETER |
| Product Code | MOU |
| Date Received | 2005-03-31 |
| Returned To Mfg | 2004-10-18 |
| Model Number | P02578 |
| Catalog Number | ABR-0346 |
| Lot Number | UNK |
| ID Number | NA |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 591859 |
| Manufacturer | NOVOSTE CORP. |
| Manufacturer Address | 4350 INTERNATIONAL BLVD. NORCROSS GA 30093 US |
| Baseline Brand Name | 3.5F BETA-RAIL DELIVERY CATHETER |
| Baseline Generic Name | CATHETER |
| Baseline Model No | P02578 |
| Baseline Catalog No | ABR-0346 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-31 |