MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-03-11 for manufactured by .
| Report Number | 1047439-2002-00007 |
| MDR Report Key | 383875 |
| Report Source | 05 |
| Date Received | 2002-03-11 |
| Date of Event | 2002-01-11 |
| Date Mfgr Received | 2002-02-13 |
| Device Manufacturer Date | 2001-03-01 |
| Date Added to Maude | 2002-03-25 |
| 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 | JAMES STAFFIERA, MGR |
| Manufacturer Street | 7575 COMMERCE COURT |
| Manufacturer City | SARASOTA FL 342433212 |
| Manufacturer Country | US |
| Manufacturer Postal | 342433212 |
| Manufacturer Phone | 9413597013 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | HOZ |
| Date Received | 2002-03-11 |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 372941 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-03-11 |