MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-21 for ROLLITE ROLLATOR 9153637242 NA:65100 65100 manufactured by Genteel.
| Report Number | 1531186-2019-00007 |
| MDR Report Key | 9215405 |
| Date Received | 2019-10-21 |
| Date of Report | 2019-10-08 |
| Date Facility Aware | 2019-10-08 |
| Report Date | 2019-10-21 |
| Date Reported to Mfgr | 2019-10-21 |
| Date Mfgr Received | 2019-10-21 |
| Date Added to Maude | 2019-10-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ROLLITE ROLLATOR 9153637242 |
| Generic Name | WALKER, MECHANICAL |
| Product Code | ITJ |
| Date Received | 2019-10-21 |
| Model Number | NA:65100 |
| Catalog Number | 65100 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENTEEL |
| Manufacturer Address | LIYU INDUSTRY AREA DANZAO, NANHAI GUANGDONG, CHINA 528216 CH 528216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-10-21 |