MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-13 for CAREX FGA22300 0000 A223-00 manufactured by Maxhealth Corp..
[175049688]
In february she was in las vegas and was walking and didn't see the curb because it was dark. When she stepped off the curb she fell and the left front wheel broke. She broke her right shoulder. She went to the emergency room. She didn't call until now because she didn't need the rolling walker until now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2020-00003 |
| MDR Report Key | 9580560 |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-02-22 |
| Date Facility Aware | 2019-12-23 |
| Report Date | 2020-01-13 |
| Date Reported to FDA | 2020-01-13 |
| Date Reported to Mfgr | 2020-01-13 |
| 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 | CAREX |
| Generic Name | STEP N REST ROLLATOR |
| Product Code | ITJ |
| Date Received | 2020-01-13 |
| Model Number | FGA22300 0000 |
| Catalog Number | A223-00 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAXHEALTH CORP. |
| Manufacturer Address | 14F, NO. 99, SECTION 1 XINTAI 5TH ROAD XIZHI DISTRICT NEW TAIPEI CITY, 22102 TW 22102 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-13 |