A
Medical Device folks, please let me have this question clarified.
A Hospital reports a complaint to a Medical Device manufacturer, then in lieu of sending the actual complaint sample back for analysis, the hospital decides to ship all of the stock in his posesion of that product back to the manufacturer for evaluation and replacement.
Should this event be classified as an Advisory Notice or not? Is the classification depending on who makes the decision to return the product? What if the decision was agreed by both the hospital and the manufacturer?
A Hospital reports a complaint to a Medical Device manufacturer, then in lieu of sending the actual complaint sample back for analysis, the hospital decides to ship all of the stock in his posesion of that product back to the manufacturer for evaluation and replacement.
Should this event be classified as an Advisory Notice or not? Is the classification depending on who makes the decision to return the product? What if the decision was agreed by both the hospital and the manufacturer?