MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-05-20 for * manufactured by *.
| Report Number | 1018233-2004-00027 |
| MDR Report Key | 528892 |
| Report Source | 05 |
| Date Received | 2004-05-20 |
| Date of Event | 2004-01-24 |
| Date Mfgr Received | 2004-04-27 |
| Date Added to Maude | 2004-06-10 |
| 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 | VIVIAN STEPHENS, MGR |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846902 |
| Manufacturer G1 | BARD MEDICAL |
| Manufacturer Street | KM 7 CARRETERA INTERNACIONAL |
| Manufacturer City | NOGALES, SONORA 84000 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 84000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | EBR |
| Date Received | 2004-05-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 518080 |
| Manufacturer | * |
| Manufacturer Address | * * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-05-20 |