MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-13 for DRIVE SSP18RBDDA manufactured by Zhenjiang Assure Medical Equipment Co Ltd.
[176298372]
Drive devilbiss healthcare is the initial importer of the device which is a wheelchair. The device has not been returned for evaluation. End-user was reclining in the chir on his patio. The back bar broke. He fell and hit his head. He sought medical attention. He had a bump on the back of his head. No cat scan or x-rays taken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2020-00002 |
| MDR Report Key | 9583739 |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-12-06 |
| Date Facility Aware | 2019-12-06 |
| Report Date | 2020-01-13 |
| Date Reported to FDA | 2020-01-13 |
| Date Reported to Mfgr | 2020-01-14 |
| Date Added to Maude | 2020-01-13 |
| 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 |
| Generic Name | WHEELCHAIR |
| Product Code | IOR |
| Date Received | 2020-01-13 |
| Model Number | SSP18RBDDA |
| Catalog Number | SSP18RBDDA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD |
| Manufacturer Address | #297 CHUQIAO ROAD ZHENJIANG CITY JIANGSU,, 212000 CH 212000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-13 |