MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-03-21 for MAMMOLUX 1360 MLX 1360 MD 4020 manufactured by R2 Technology, Inc..
[477817]
During one of these processes the technician's attention was diverted and her arm was caught in the upper belt intake area. The motorized viewer shut off automatically. Once the viewer was stopped, the tech was able to remove her arm. The tech reported "soft tissue damage" (bruising) to her arm. Her arm was placed in a sling. She missed two days of work before returning to normal duties. The technician's injury has since resolved completely. The device is labeled using international symbology warning user to be aware of the danger of getting hands caught in the moving parts of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953690-2006-00001 |
| MDR Report Key | 690609 |
| Report Source | 06 |
| Date Received | 2006-03-21 |
| Date of Report | 2006-03-20 |
| Date of Event | 2006-02-20 |
| Date Mfgr Received | 2006-02-21 |
| Device Manufacturer Date | 2002-02-01 |
| Date Added to Maude | 2006-03-23 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | RICHARD BALL |
| Manufacturer Street | 1195 W FREMONT AVE. |
| Manufacturer City | SUNNYVALE CA 94087 |
| Manufacturer Country | US |
| Manufacturer Postal | 94087 |
| Manufacturer Phone | 4084815613 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAMMOLUX 1360 |
| Generic Name | MOTORIZED X-RAY VIEWER |
| Product Code | IXC |
| Date Received | 2006-03-21 |
| Model Number | MLX 1360 |
| Catalog Number | MD 4020 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 679757 |
| Manufacturer | R2 TECHNOLOGY, INC. |
| Manufacturer Address | * SUNNYVALE CA * US |
| Baseline Brand Name | MAMMOLUX 1360 |
| Baseline Generic Name | MOTORIZED X-RAY VIEWER |
| Baseline Model No | MLX 1360 |
| Baseline Catalog No | MD 4020 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-03-21 |