Drive devilbiss healthcare is the initial importer of the device which is a rollator.We are filing this report in an over-abundance of caution due to an mdr regression analysis.The device was not returned for evaluation, however, a photo was provided.The end-user was sitting on the device in the kitchen.She was using her feet to push herself backwards when the wheel snapped.She was transported to the emergency room and diagnoses with a bruised hip.She had no caregiver so was unable to return the unit for evaluation.The device is a rollator and intended as a mobility device that can be used to sit and rest as needed.It is not a transportation device.The instructions for use warn against using the device as a transportation device.Historical complaints data of the same nature was very limited with no trend.Possible root cause for the incident could be the users backward movement while sitting using her feet.This is considered misuse.This will be considered an isolated incident.
|