MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-29 for MED CHOICE 2867BTH231 manufactured by Unk.
[53914555]
Pt sitting on med choice shower chair washing up at sink. Chair leg collapsed and the pt fell hitting her hip and head. Event abated after use stopped or dose reduced? Yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064475 |
| MDR Report Key | 5920443 |
| Date Received | 2016-08-29 |
| Date of Report | 2016-08-29 |
| Date of Event | 2016-08-29 |
| Date Added to Maude | 2016-09-01 |
| 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 | 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 | MED CHOICE |
| Generic Name | SHOWER CHAIR |
| Product Code | KMN |
| Date Received | 2016-08-29 |
| Model Number | 2867BTH231 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-29 |