MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2001-02-02 for VISION FP 202 manufactured by Smv International.
[19168728]
Transformation of a tomo dataset from vision into interfile is ok but transformation of this interfile into original dataset change x and y values.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615727-2001-00002 |
| MDR Report Key | 315451 |
| Report Source | 00 |
| Date Received | 2001-02-02 |
| Date of Report | 2001-02-01 |
| Date of Event | 2001-01-22 |
| Date Mfgr Received | 2001-01-22 |
| Date Added to Maude | 2001-02-13 |
| 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 | MARCO TIRELLI |
| Manufacturer Street | 105 AV. MORANE-SAULNIER |
| Manufacturer City | BUC CEDEX 78534 |
| Manufacturer Country | FR |
| Manufacturer Postal | 78534 |
| Manufacturer Phone | 0849100 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | UNK |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISION |
| Generic Name | COMPUTER |
| Product Code | JWM |
| Date Received | 2001-02-02 |
| Model Number | VISION |
| Catalog Number | FP 202 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 305048 |
| Manufacturer | SMV INTERNATIONAL |
| Manufacturer Address | 105 AV. MORANE-SAULNIER BUC CEDEX FR 78534 |
| Baseline Brand Name | VISION |
| Baseline Generic Name | COMPUTER |
| Baseline Model No | VISION |
| Baseline Catalog No | FP 202 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-02-02 |