MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-13 for WRX276741V1 manufactured by Medline Industries Inc..
[186542432]
It was reported that while walking up a handicap access ramp with a rollator, the right handle of the rollator "flew-out" to the right resulting in the end-user experiencing a fall to the ground. The end-user was able to get back to her feet with the assistance of two other individuals (her daughter and neighbor) with no immediate injury noted. Her daughter took the end-user to the emergency room later that day for evaluation. The end-user reports x-rays taken. End-user reports a surface cut to the left leg that required bandaging but no serious injuries. End-user released from the er without further treatment and instructed to follow-up with her primary care physician (pcp). Upon follow-up, the pcp confirmed she had experienced a scaphoid fracture of the right hand with no additional fractures noted. End-user states there is no treatment at this time for a scaphoid fracture. The walker has not been returned to the manufacturer for evaluation as of the date of this report. Due to the reported incident and in an abundance of caution this medwatch is being filed. If additional relevant information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186542433]
It was reported that while walking up a handicap access ramp with a rollator, the right handle of the rollator "flew-out" to the right resulting in the end-user experiencing a fall to the ground and a scaphoid fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2020-00006 |
| MDR Report Key | 9707646 |
| Report Source | CONSUMER |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-02-13 |
| 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 Contact | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD, IL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | WALKER, BLUE, FOLDING, W/WHEELS, WAGS PL |
| Product Code | ITJ |
| Date Received | 2020-02-13 |
| Catalog Number | WRX276741V1 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-13 |