EACH DEVICE IS MANUFACTURED TO ORDER ACCORDING TO EACH PATIENTS' ANATOMY. AS SUCH, A DEVICE IS NOT TO BE USED BY DIFFERENT PATIENTS, BUT RATHER BY A SINGLE PATIENT FOR SEVERAL MONTHS. PLEASE NOTE THAT A PRODUCTION ACCOUNT FOR THE ELECTRONIC SUBMISSIONS GATEWAY (ESG) WAS INITIATED ON 6/7/2016. NOTIFICATION WAS RECEIVED ON 7/1/2016 THAT THE TEST SUBMISSION FAILED. A NEW TEST SUBMISSION WAS SENT ON 7/1/2016. THE PRODUCTION ACCOUNT WAS APPROVED ON 7/5/2016. THIS REPORT WAS IMMEDIATELY FILED ON 7/5/2016. NOTIFICATION WAS RECEIVED ON 7/7/2016 THAT THE SUBMISSION FAILED. A NEW SUBMISSION WAS SENT ON 7/7/2016.
D
Patient 1
ON (B)(6) 2016, PATIENT'S PARENT NOTICED THAT A WIRE (.032" DIAMETER AND APPROXIMATELY 21 MM IN LENGTH) FROM THE EXPANDER WAS MISSING. THE PATIENT WAS NOT AWARE THAT THE WIRE CAME OFF AND IN ADVERTENTLY SWALLOWED THE WIRE. PATIENT WENT TO EMERGENCY ROOM TO SEEK MEDICAL ATTENTION. ON (B)(6), PATIENT RECEIVED A FOLLOW-UP X RAY. ON (B)(6), PATIENT WAS ADVISED THAT THE WIRE HAD PASSED AND WAS RELEASED. SUBSEQUENTLY ON (B)(6), PATIENT FELT A SHARP WIRE IN HER MOUTH. AN OCCLUSAL REST CAME OFF AND THE PATIENT SWALLOWED THE WIRE. PATIENT SOUGHT TREATMENT AT THE EMERGENCY ROOM. X RAYS WERE TAKEN TO LOCATE THE WIRE. THE WIRE WAS FOUND IN THE SMALL INTESTINE. PATIENT WAS ADVISED THAT WIRE WOULD PASS AND TO COME BACK IF SHE EXPERIENCED CRAMPING, BLEEDING OR PAIN. THE HERBST APPLIANCE WAS SEATED ON (B)(6) 2016 AND WAS REMOVED ON (B)(6) 2016.