As stated in the event description, on (b)(6) 2020, ad-tech's sales manager was notified via email, of an issue from one of their distributors.The distributor had stated that they had received a complaint from a customer stating that one (1) 6-contact depth electrode ".Had ended with blood +/- cerebral spinal fluid (csf) entering the electrode shaft." a follow up email was sent to the distributor on march 10, 2020 requesting additional information, including if there was any impact to patient safety.Ad-tech is currently awaiting a response.According to the customer, they were concerned about this as it presents a potential infection risk.Ad-tech performed a preliminary risk assessment of the issue.The event identified an inadequate hermetic seal of the brain end contacts and therefore, the most applicable harm was deemed, "biological - adverse or allergic reaction".
|
On (b)(6) 2020, ad-tech's sales manager was notified via email, of an issue from one of their distributors.The distributor had stated that they had received a complaint from a customer stating that one (1) 6-contact depth electrode ".Had ended with blood +/- cerebral spinal fluid (csf) entering the electrode shaft." a follow up email was sent to the distributor on march 10, 2020 requesting additional information, including if there was any impact to patient safety.Ad-tech is currently awaiting a response.
|