MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-17 for HOVERMATT manufactured by .
[5236660]
Patient on excel care es bariatric bed with hovermatt deflated between patient and mattress. Patient stated she was sleeping and woke up as her leg slide out of bed and her entire body slide out with it. Patient yelled for help and staff found her on the floor with the hovermatt on floor with her. Three side rails were up. Patient was taken provided emergent care and films taken. Patient was able to have fractures immediately repaired due to underlying issues. Patient was ultimately transferred to (b)(6) where she expired on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039708 |
| MDR Report Key | 4360671 |
| Date Received | 2014-12-17 |
| Date of Report | 2014-12-17 |
| Date of Event | 2014-11-20 |
| Date Added to Maude | 2014-12-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOVERMATT |
| Generic Name | SAFE PATIENT HANDLING DEVICE |
| Product Code | FRZ |
| Date Received | 2014-12-17 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-12-17 |