MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-13 for UNKNOWN manufactured by Unknown.
[145001305]
The patient was sitting in a recliner in same day surgery. The brakes were applied to the recliner. The patient was obese and was moving around a lot in the chair while trying to get dressed. The recliner moved and the patient fell out of the chair and suffered a fractured ankle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8605658 |
| MDR Report Key | 8605658 |
| Date Received | 2019-05-13 |
| Date of Report | 2019-03-05 |
| Date of Event | 2018-12-06 |
| Report Date | 2019-03-05 |
| Date Reported to FDA | 2019-03-05 |
| Date Reported to Mfgr | 2019-04-10 |
| Date Added to Maude | 2019-05-13 |
| 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 | UNKNOWN |
| Generic Name | CHAIR, ADJUSTABLE, MECHANICAL |
| Product Code | INN |
| Date Received | 2019-05-13 |
| Device Availability | Y |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-05-13 |