MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-09-17 for * manufactured by *.
| Report Number | 1018233-2004-00062 |
| MDR Report Key | 545547 |
| Report Source | 00 |
| Date Received | 2004-09-17 |
| Date of Event | 2004-07-26 |
| Date Mfgr Received | 2004-08-20 |
| Date Added to Maude | 2004-09-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 | BARD MEDICAL |
| Manufacturer Street | 428 POWERHOUSE ROAD |
| Manufacturer City | MONCKS CORNER SC 29461 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29461 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Product Code | KDH |
| Date Received | 2004-09-17 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 534979 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-09-17 |