MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-19 for DRIVE MEDICAL 11117N-1 manufactured by Zhongshan Rexon Rehabilitation Equipment Company.
[75598826]
(b)(4) received notification of an incident involving a commode chair that (b)(4) imports and distributes. The enduser was attempting to remove the commode bucket and allegedly, the toilet seat became unhinged causing her to fall. She was allegedly taken to the emergency room at (b)(6) hospital and had x-rays taken. She suffered a hairline fracture in her right elbow. The enduser requested a replacement commode chair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2017-00049 |
| MDR Report Key | 6580216 |
| Date Received | 2017-05-19 |
| Date of Report | 2017-04-21 |
| Date Facility Aware | 2017-04-21 |
| Report Date | 2017-05-19 |
| Date Reported to FDA | 2017-05-19 |
| Date Reported to Mfgr | 2017-05-19 |
| Date Added to Maude | 2017-05-19 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 3 |
| Brand Name | DRIVE MEDICAL |
| Generic Name | COMMODE CHAIR |
| Product Code | IKX |
| Date Received | 2017-05-19 |
| Model Number | 11117N-1 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZHONGSHAN REXON REHABILITATION EQUIPMENT COMPANY |
| Manufacturer Address | 56 SHANGYE STREET 3TH INDUSTRIAL PARK CHENGGUI ROAD WUGUISHAN, GUANGDONG 528458 CH 528458 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-05-19 |