MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-07-17 for manufactured by .
| Report Number | 1030322-2002-00009 |
| MDR Report Key | 405941 |
| Report Source | 05,06 |
| Date Received | 2002-07-17 |
| Date of Event | 2002-06-24 |
| Date Mfgr Received | 2002-07-12 |
| Date Added to Maude | 2002-07-23 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | RICHARD KOZLOFF |
| Manufacturer Street | 7100 30TH AVE NORTH |
| Manufacturer City | ST PETERSBURG FL 33710 |
| Manufacturer Country | US |
| Manufacturer Postal | 33710 |
| Manufacturer Phone | 7273842323 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | FTF |
| Date Received | 2002-07-17 |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 394930 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-07-17 |