MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-28 for UNKNOWN manufactured by Unk.
[131907321]
Pt was in activity area at nursing facility with other residents and 2 staff personal. Pt slid from broda chair while staff were assisting other residents. Pt was found lying on left side with bleeding noted from head. Pt was given first aide by facility staff. Transported to (b)(6) hosp emergency room. Hme was notified of incident, at this time mfr of chair is unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8208264 |
| MDR Report Key | 8208264 |
| Date Received | 2018-12-28 |
| Date of Report | 2018-12-28 |
| Date of Event | 2018-12-10 |
| Date Facility Aware | 2018-12-10 |
| Report Date | 2018-12-28 |
| Date Reported to FDA | 2018-12-28 |
| Date Added to Maude | 2019-01-02 |
| 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 | BRODA CHAIR |
| Product Code | INN |
| Date Received | 2018-12-28 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization | 2018-12-28 |