MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for DRIVE 51293RED manufactured by Ningbo Shenyu Medical Equipment Co., Ltd.
[184252684]
Drive deviilbiss healthcare is the initial importer of the device which is a rollator. The device has not ben returned for evaluation. Our post market surveillance associate has not been able to get clarification of the incident. We are filing this report in an overabundance of caution in order to be timely. End-user was siting on her bed. She stood and then sat back down. She pushed her rollator and it caught her leg causing a gash which required 12 stitches in her leg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2020-00013 |
| MDR Report Key | 9729888 |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-20 |
| Date Facility Aware | 2020-01-20 |
| Report Date | 2020-02-19 |
| Date Reported to FDA | 2020-02-19 |
| Date Reported to Mfgr | 2020-02-20 |
| Date Added to Maude | 2020-02-19 |
| 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 |
| 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 | ROLLATOR |
| Product Code | ITJ |
| Date Received | 2020-02-19 |
| Model Number | 51293RED |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 13 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD |
| Manufacturer Address | WEST OF TANJIALING ROAD YUYAO ZHEJIANG 315408 CH 315408 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-02-19 |