MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-23 for UNK manufactured by Unk.
[112321811]
Patient Sequence No: 1, Text Type: N, H10
[112321812]
The patient was in the bathroom on the toilet and the caregiver transferred patient to the wheelchair. The patient slid out of the wheelchair onto the floor and her right leg became wedged between the door and part of the wheelchair. After the fall, the patient was having increased pain and inability to stand, and her right foot appeared to be turned inward. An x-ray was ordered of the right leg that showed an acute fracture of the right femoral neck, displaced about 1cm with mild varus angulation. Hme was notified of the event and the mfr is unk, the wheelchair was the patient's private wheelchair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7633577 |
| MDR Report Key | 7633577 |
| Date Received | 2018-03-23 |
| Date of Report | 2018-03-23 |
| Date of Event | 2018-01-09 |
| Date Facility Aware | 2018-01-09 |
| Report Date | 2018-03-23 |
| Date Reported to FDA | 2018-03-23 |
| Date Added to Maude | 2018-06-25 |
| 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 |
| Generic Name | WHEELCHAIR |
| Product Code | IML |
| Date Received | 2018-03-23 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2018-03-23 |