At the initial assessment of this complaint, it was determined that this was not a reportable event as there was no patient impact and the risk of patient harm was thought to be remote at the time.However, during the 2022 fda inspection, it was suggested ad-tech re-evaluate the reportability for this complaint.Fda advised ad-tech that as later complaints for "bent electrode" were considered reportable due to risk file interpretation based on clinician input, earlier complaints should have also be reported.Therefore, mdr 2183456-2022-00011 has been filed past the 30-day timeframe.As documented within the complaint, there was no impact to the patient as a result of this issue.Per our risk assessment, the risk remains alap (as low as possible) and matches that of the risk file.No updates to the risk file are needed at this time.The bent electrodes were not returned to ad-tech, therefore, no further evaluation could be performed.The cause was deemed inconclusive as very little information was obtained from the complainant.This complaint was closed and the trend code is being monitored for future occurrence.
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