A device history record review was not conducted, based upon review of the information provided by the customer, as it does not indicate a problem with the initial manufacture or prior repair of the device.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.It was reported that the patient presented with cellulitis at infusion site.No medical or surgical intervention was reported.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
|