MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-09 for PREVALON LIFTAEM MOBILE PATIENT TRANSFER SYSTEM 3139 manufactured by Sage Products Llc.
[51495559]
Patient Sequence No: 1, Text Type: N, H10
[51495560]
Patient was positioned for a laparoscopic roux-en-y gastric bypass procedure. During the procedure the patient had slid down the operating room table approximately 9 inches. The patient was positioned and secured as usually required for the procedure. A foot board was not in place for this procedure. Pt. On the operating room table in reverse trendelenburg position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5856194 |
| MDR Report Key | 5856194 |
| Date Received | 2016-08-09 |
| Date of Report | 2016-08-03 |
| Date of Event | 2016-08-02 |
| Report Date | 2016-08-03 |
| Date Reported to FDA | 2016-08-03 |
| Date Reported to Mfgr | 2016-08-03 |
| Date Added to Maude | 2016-08-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | PREVALON LIFTAEM MOBILE PATIENT TRANSFER SYSTEM |
| Generic Name | DEVICE, TRANSFER, MANUAL |
| Product Code | FMR |
| Date Received | 2016-08-09 |
| Catalog Number | 3139 |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAGE PRODUCTS LLC |
| Manufacturer Address | 3909 THREE OAKS ROAD CARY IL 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-09 |