MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-23 for RAE MOBILE SHOWER COMMODE CHAIR manufactured by Raz Design Inc..
[134195719]
Pt with history of cervical spinal cord injury and quadriparesis was placed in shower chair and rolled into shower by a staff member. When staff shifted pt in order to have her sit straight, the chair cushion fell through the hole in the frame. No injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083316 |
| MDR Report Key | 8273995 |
| Date Received | 2019-01-23 |
| Date of Report | 2019-01-17 |
| Date of Event | 2019-01-01 |
| Date Added to Maude | 2019-01-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | RAE MOBILE SHOWER COMMODE CHAIR |
| Generic Name | CHAIR ADJUSTABLE MECHANICAL |
| Product Code | INN |
| Date Received | 2019-01-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | RAZ DESIGN INC. |
| Manufacturer Address | NIAGARA FALLS NY US |
| Brand Name | RAE MOBILE SHOWER COMMODE CHAIR |
| Generic Name | CHAIR ADJUSTABLE MECHANICAL |
| Product Code | INN |
| Date Received | 2019-01-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAE DESIGN INC. |
| Manufacturer Address | NIAGARA FALLS NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-23 |