MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-02-18 for * manufactured by Lifenet.
| Report Number | 1124603-2005-00005 |
| MDR Report Key | 577159 |
| Report Source | 05 |
| Date Received | 2005-02-18 |
| Date of Report | 2005-02-18 |
| Date of Event | 2004-09-02 |
| Date Mfgr Received | 2005-02-14 |
| Date Added to Maude | 2005-03-03 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAVID KLEMENTOWSKI |
| Manufacturer Street | 5809 WARD COURT |
| Manufacturer City | VIRGINIA BEACH VA 23452 |
| Manufacturer Country | US |
| Manufacturer Postal | 23452 |
| Manufacturer Phone | 7572274552 |
| 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 | * |
| Generic Name | TISSUE HOMOGRAFT |
| Product Code | LMO |
| Date Received | 2005-02-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 01-3064HV01 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 566999 |
| Manufacturer | LIFENET |
| Manufacturer Address | * VIRGINIA BEACH VA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-02-18 |