MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for 5 IN FIXED DUAL RELEASE WALKER 9153634176 NA:6291-5F 6291-5F manufactured by Fujian Xiang Xin Hardware Technology Co. Ltd.
[175228984]
Additional information gathered from the dealer provided that the end user lost his balance while using the 6291-5f invacare walker outside on the concrete. The dealer stated,? The handles were just wobbly, not the whole rollator?. Also, they are not sure if the end user lost his balance and fell on the walker or if it was the fault of the walker. The walker was requested to be returned, however the dealer was unable to locate it. The walker has been replaced. The end user did not receive any medical treatment for the fractured nose. The owner? S manual for this device includes the following warnings/instructions: maintenance should be done at least every six months. Regular inspection of parts including hardware, brackets, and plastics, for deformation, corrosion, breakage, wear or compression is recommended. Replace the walker if any of these conditions exist. Ensure the handgrips do not twist on side frame. The handgrips must be tight. Do not use the walker if the handgrips are loose. Replace the walker if the handgrips are loose on the side frame(s).
Patient Sequence No: 1, Text Type: N, H10
[175228985]
The end user was using the walker outside and fell forward, fracturing his nose. He claimed the handles were wobbly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2020-00003 |
| MDR Report Key | 9587525 |
| Date Received | 2020-01-14 |
| Date of Report | 2019-08-26 |
| Date Facility Aware | 2019-09-09 |
| Report Date | 2020-01-14 |
| Date Reported to FDA | 2020-01-14 |
| Date Reported to Mfgr | 2020-01-14 |
| Date Mfgr Received | 2019-09-09 |
| Device Manufacturer Date | 2018-08-01 |
| Date Added to Maude | 2020-01-14 |
| 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 |
| 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 | 3 |
| Brand Name | 5 IN FIXED DUAL RELEASE WALKER 9153634176 |
| Generic Name | WALKER |
| Product Code | ITJ |
| Date Received | 2020-01-14 |
| Model Number | NA:6291-5F |
| Catalog Number | 6291-5F |
| Lot Number | FX180801 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FUJIAN XIANG XIN HARDWARE TECHNOLOGY CO. LTD |
| Manufacturer Address | LAN JIAO SHENG INDUSTRIAL AREA FUZHOU, FUJIAN CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-14 |