AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. WITHOUT THE RETURN OF THE PRODUCT, NO CONCLUSIONS CAN BE MADE REGARDING THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING PATIENT INFORMATION, PATIENT OUTCOME, AND WHETHER PATIENT RECEIVED ADDITIONAL INTERVENTION. AT THIS TIME NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO RESPIRATORY TECHNOLOGIES. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
D
Patient 1
RESPIRATORY TECHNOLOGIES RECEIVED INFORMATION DURING ROUTINE FOLLOW-UP THAT A PATIENT EXPERIENCED A RUPTURE OF ONE OF THE PATIENT'S SALINE BREAST IMPLANTS FOLLOWING THE USE OF THE INCOURAGE AIRWAY CLEARANCE THERAPY SYSTEM. THERE HAVE BEEN NO ADVERSE EVENTS REPORTED BY THE PATIENT IN THE MONTHS SINCE THE EVENT OCCURRED. THE PATIENT HAD CONSULTED WITH HER PHYSICIAN AND THE PHYSICIAN STATED THERE ARE NO RISKS DUE TO THE RUPTURE. THE INCOURAGE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS, BUT PRODUCT RETURN IS EXPECTED.