MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-05-09 for VISION manufactured by Smv Intl..
[171143]
Image quality is drastically affected after resolution recovery and attenuation correction.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9615727-2000-00011 |
MDR Report Key | 278708 |
Report Source | 00 |
Date Received | 2000-05-09 |
Date of Report | 2000-05-09 |
Date of Event | 2000-04-12 |
Date Facility Aware | 2000-04-12 |
Report Date | 2000-05-09 |
Date Mfgr Received | 2000-04-12 |
Date Added to Maude | 2000-05-24 |
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 | 3 |
Manufacturer Contact | MARCO TIRELLI |
Manufacturer Street | 105 AV. MORANE-SAULNIER |
Manufacturer City | BUC CEDEX 78534 |
Manufacturer Country | FR |
Manufacturer Postal | 78534 |
Manufacturer Phone | 0849241 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VISION |
Generic Name | COMPUTER |
Product Code | JWM |
Date Received | 2000-05-09 |
Model Number | NA |
Catalog Number | NA |
Lot Number | NA |
ID Number | NA |
Operator | OTHER |
Device Availability | Y |
Device Age | NA |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 269728 |
Manufacturer | SMV INTL. |
Manufacturer Address | 105 AV. MORANE-SAULNIER BUC CEDEX FR 78534 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2000-05-09 |