We are unable to determine if the jada device malfunctioned or if the patient experienced any adverse effects from the reported expulsion of her jada device as the requested additional information has not been provided as of 09/16/2021.Out of an abundance of caution and because we cannot rule a malfunction out at this time, we are reporting this event due to the 30-day reporting deadline.If we become aware of additional information, we will supplement this report.The submission of this report is not an admission that device caused or contributed to any event.
|