MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-05 for WRX490530 manufactured by Medline Industries Inc..
[177988791]
It was reported that the rollator brakes disengaged as the end-user was getting up from a bedside commode. The end-user fell onto wood laminate flooring, was assisted back up by a family member, and brought to a local hospital's emergency department (ed). An unspecified x-ray was obtained in the ed and the end-user was diagnosed with an unspecified femur fracture. The end-user received unspecified pain medication in the ed and surgical intervention for the reported femur fracture. She was admitted to the hospital for five (5) days and was then admitted to a rehabilitation facility for twenty (20) days. No additional medical intervention or follow-up care was reported to the manufacturer. No sample was returned to the manufacturer for evaluation. A root cause for the reported incident was unable to be determined. Due to the reported femur fracture, hospital admission, and rehabilitation facility admission, 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
[177988792]
It was reported that the rollator brakes disengaged and the end-user experienced a fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2020-00005 |
| MDR Report Key | 9671579 |
| Report Source | CONSUMER |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-06-01 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-05 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ROLLATOR, KNOCK DOWN, WGNS |
| Product Code | ITJ |
| Date Received | 2020-02-05 |
| Catalog Number | WRX490530 |
| 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 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2020-02-05 |