Patient required hospitalization to administer antibiotics and debridement.Device investigation narrative - examination is not possible, as the devices will not be returned.Based on the nature of the complaint, a review of the sterility records was conducted.The products were sterilized per specifications.All process parameters were confirmed to be within specification.No abnormalities were reported with these products during manufacture.The information provided is insufficient to determine whether the patient¿s symptoms, signs or outcome are due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the product, one or more of its components, or its intended therapeutic action.A thorough medical assessment cannot be rendered at this time.Further investigation is not warranted at this time.(b)(4).
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