MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-21 for SKYTRON 3600B * manufactured by Skytron.
[1093840]
>300lb pt on bed when it loosened from post and fell. Pt in steep trendelenburg. Pt slipped from bed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1427703 |
| MDR Report Key | 1427703 |
| Date Received | 2009-07-21 |
| Date of Report | 2009-06-22 |
| Date of Event | 2009-03-25 |
| Report Date | 2009-06-22 |
| Date Reported to FDA | 2009-07-21 |
| Date Added to Maude | 2009-08-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | SKYTRON 3600B |
| Generic Name | TABLE, SURGICAL |
| Product Code | BWN |
| Date Received | 2009-07-21 |
| Model Number | 3600B |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKYTRON |
| Manufacturer Address | 5085 CORPORATE EXCHANGE BLVD. GRAND RAPIDS MI 49512 US 49512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-21 |