MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-11 for DRIVE MEDICAL ATC19-BL manufactured by Danyang Jumao Healthcare Equipment Co.,ltd.
[74948400]
(b)(4) received notice about this claim from the dme provider, (b)(6), involving a transport chair, a product imported and distributed by (b)(4). The end user went to sit in the chair when the folding hinges allegedly broke causing the end user to fall. Emergency services were called to help the patient get up. No injuries was reported. (b)(4) is in the process of getting the product back to further the investigation. This report is based on the information that was provided by the provider.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2017-00045 |
| MDR Report Key | 6560675 |
| Date Received | 2017-05-11 |
| Date of Report | 2017-04-13 |
| Date of Event | 2017-04-12 |
| Date Facility Aware | 2017-04-13 |
| Report Date | 2017-05-11 |
| Date Reported to FDA | 2017-05-11 |
| Date Reported to Mfgr | 2017-05-11 |
| Date Added to Maude | 2017-05-11 |
| 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 |
| 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 | CHAIR, WITH CASTERS |
| Product Code | INM |
| Date Received | 2017-05-11 |
| Model Number | ATC19-BL |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD |
| Manufacturer Address | NO.36 DANYAN ROAD DANYANG CITY, JIANGSU PROVINCE JIANGSU 212300 CH 212300 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-11 |