MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-04 for PREVALON LIFTAEM MOBILE PATIENT TRANSFER SYSTEM manufactured by Sage Products Llc.
[56510497]
Patient Sequence No: 1, Text Type: N, H10
[56510498]
The patient was supine on the operating room table secured with safety straps at the hip and bilateral lower extremity. The patient was placed in slight reverse trendelenburg and tilted towards both surgeon and scrub tech. The patient slid to side onto both surgeon and scrub tech. Patient pushed back onto the bed and transfer pad removed immediately. Patient assessed and procedure resumed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5996507 |
| MDR Report Key | 5996507 |
| Date Received | 2016-10-04 |
| Date of Report | 2016-08-31 |
| Date of Event | 2016-08-26 |
| Report Date | 2016-08-29 |
| Date Reported to FDA | 2016-08-29 |
| Date Reported to Mfgr | 2016-08-29 |
| Date Added to Maude | 2016-10-04 |
| 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 | 0 |
| Brand Name | PREVALON LIFTAEM MOBILE PATIENT TRANSFER SYSTEM |
| Generic Name | TRANSFER MAT |
| Product Code | FMR |
| Date Received | 2016-10-04 |
| Device Availability | * |
| 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 3 OAKS ROAD CARY IL 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-04 |