MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-12-22 for NXT NA manufactured by Smv International.
[77762]
Frames displayed and pt's name written are discordant
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528274-1997-00035 |
| MDR Report Key | 139781 |
| Report Source | 00 |
| Date Received | 1997-12-22 |
| Date of Report | 1997-12-18 |
| Date of Event | 1997-11-30 |
| Date Mfgr Received | 1997-12-11 |
| Device Manufacturer Date | 1992-11-01 |
| Date Added to Maude | 1997-12-29 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NXT |
| Generic Name | COMPUTER |
| Product Code | JWM |
| Date Received | 1997-12-22 |
| Model Number | NXT |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 136471 |
| Manufacturer | SMV INTERNATIONAL |
| Manufacturer Address | 41, RUE FOURNY Z1 NORD BP 112 BUC CEDEX * 78534 |
| Baseline Brand Name | NXT |
| Baseline Generic Name | COMPUTER |
| Baseline Model No | NXT |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-12-22 |