MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-09 for SKYTRON 4-030-18 manufactured by Skytron, Llc.
[77218041]
Patient Sequence No: 1, Text Type: N, H10
[77218042]
A black sling used to support the patient's legs pre- and post- gyn procedure twisted at the site of attachment to the bed. The patient's right leg dropped to floor, left leg was caught and supported. An ortho consult was placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6629919 |
| MDR Report Key | 6629919 |
| Date Received | 2017-06-09 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-01-31 |
| Report Date | 2017-05-17 |
| Date Reported to FDA | 2017-05-17 |
| Date Reported to Mfgr | 2017-05-17 |
| Date Added to Maude | 2017-06-09 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON |
| Generic Name | DEVICE, TRANSFER, PATIENT, MANUAL |
| Product Code | FMR |
| Date Received | 2017-06-09 |
| Model Number | 4-030-18 |
| Catalog Number | 4-030-18 |
| Lot Number | I16 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKYTRON, LLC |
| Manufacturer Address | 5085 CORPORATE EXCHANGE BLVD. SE GRAND RAPIDS MI 49512 US 49512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-09 |