Description of Event or Problem · 1
I WANTED TO REPORT THE MIGRATION OF A "BREATHE WITH EEZ" NASAL SPRING. THE NASAL DILATOR WAS SMALL IN SIZE BUT QUITE SECURE IN ITS POSITION AT THE NASAL VALVE. THE PATIENT NOTES THE RIGHT SIDE EXTRUDED ANTERIORLY BUT THE LEFT SIDE SHE WAS NEVER ABLE TO FIND. ON TELESCOPIC RHINOSCOPY, I WAS ABLE TO RETRIEVE THE NASL DILATOR FROM THE POSTERIOR ASPECT OF HER NASAL CHAMBER WEDGED BETWEEN HER INFERIOR TURBINATE AND HER NASAL SEPTUM. A SALESMAN THAT PASSED TOLD ME THESE DEVICES DO NOT MIGRATE POSTERIORLY BUT I WANTED YOU TO KNOW THAT AT LEAST ON THIS PATIENT MIGRATION HAS HAPPENEDINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.