MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-20 for ADNEXA B130 * manufactured by Adnexa Corp.
[500014]
An x-ray tube came off the arm of the tube crane and fell to the floor. As the tube -100 lbs. - was falling, it hit a staff member's arm and thigh, causing injury to both. The mfr was notified, the arm was replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036979 |
| MDR Report Key | 748556 |
| Date Received | 2005-10-21 |
| Date of Report | 2005-10-20 |
| Date of Event | 2005-10-12 |
| Date Added to Maude | 2006-08-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADNEXA |
| Generic Name | DIGITAL X-RAY TUBE |
| Product Code | ITY |
| Date Received | 2005-10-20 |
| Returned To Mfg | 2005-10-14 |
| Model Number | B130 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 736339 |
| Manufacturer | ADNEXA CORP |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-10-21 |