MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-24 for UNKNOWN manufactured by Unknown.
[70789479]
Patient Sequence No: 1, Text Type: N, H10
[70789480]
No identifying data available for the chair. (b)(6) around 10am the significant other of the patient was sitting in recliner chair and upon standing from the chair he twisted his ankle by slipping off the black foot rest that was pulled out from underneath the chair. He felt his left ankle twist but did not think it was so bad at the time. This morning i was informed of the incident as the patient states that the pain has increased and has localized swelling. The patient was present for the incident. The rn and cn were not aware of any incident that took place on that day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6431660 |
| MDR Report Key | 6431660 |
| Date Received | 2017-03-24 |
| Date of Report | 2017-03-08 |
| Date of Event | 2016-09-13 |
| Report Date | 2017-03-08 |
| Date Reported to FDA | 2017-03-08 |
| Date Reported to Mfgr | 2017-03-08 |
| Date Added to Maude | 2017-03-24 |
| 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 | UNKNOWN |
| Generic Name | CHAIR, EXAMINATION AND TREATMENT |
| Product Code | FRK |
| Date Received | 2017-03-24 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-24 |