MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-04-30 for SKYTRON 4-030-18 manufactured by Amatech.
[19406261]
During a surgical case, the pt's legs were positioned on a transfer board when the board dislodged from the table causing the pt to begin to fall. The pt was caught by a surgery technician. The pt was caught by a surgery tech. The tech report injuries to her wrist and back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825014-2015-00016 |
| MDR Report Key | 4749786 |
| Report Source | 99 |
| Date Received | 2015-04-30 |
| Date of Report | 2015-04-17 |
| Date Facility Aware | 2014-04-07 |
| Report Date | 2015-04-17 |
| Date Reported to FDA | 2015-04-17 |
| Date Reported to Mfgr | 2015-04-17 |
| Date Added to Maude | 2015-05-06 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON |
| Generic Name | TRANSFER BOARD |
| Product Code | FMR |
| Date Received | 2015-04-30 |
| Model Number | 4-030-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMATECH |
| Manufacturer Address | ACTON MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-30 |