MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-01-23 for CAREX A226 manufactured by Carex Health Brands.
[1018699]
Carex transport chair a226, in 2009, left brake did not hold; patient getting up in bathroom. Grabbed bar on wall and reached for transport chair; chair moved and patient fell. Outcome: patient reported sore on right shoulder. In 2008- patient noticed brake problem; patient's son-in-low worked on it with wrench, thought it was ok. Noticed intermittent problem after. Dates of use: one month.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009727 |
| MDR Report Key | 1296169 |
| Date Received | 2009-01-23 |
| Date of Report | 2009-01-23 |
| Date Added to Maude | 2009-02-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAREX |
| Generic Name | TRANSPORT CHAIR |
| Product Code | FRJ |
| Date Received | 2009-01-23 |
| Model Number | A226 |
| ID Number | 07VT022894 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREX HEALTH BRANDS |
| Manufacturer Address | SIOUX FALLS SD 57104 US 57104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-23 |