MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2003-12-02 for * VTI-102 103102 manufactured by *.
| Report Number | 2531249-2003-00001 |
| MDR Report Key | 500650 |
| Report Source | 05,06,08 |
| Date Received | 2003-12-02 |
| Date of Event | 2003-10-13 |
| Date Mfgr Received | 2003-10-22 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2003-12-15 |
| 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 Street | 159 GILBRALTAR RD |
| Manufacturer City | HORSHAM PA 19044 |
| Manufacturer Country | US |
| Manufacturer Postal | 19044 |
| Manufacturer Phone | 2156757714 |
| 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 |
| Brand Name | * |
| Generic Name | * |
| Product Code | CCL |
| Date Received | 2003-12-02 |
| Model Number | VTI-102 |
| Catalog Number | 103102 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 489418 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Baseline Brand Name | * |
| Baseline Generic Name | * |
| Baseline Model No | VTI-102 |
| Baseline Catalog No | 103102 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-12-02 |