PROPEL
Received Feb 11, 2015 · Event occurred Feb 10, 2015
Report MW5040781 · MDR key 4528366
Device
Generic name
Instrument
Manufacturer
Propel OrthodonticsProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
39 YR
- Headache
- Hyperventilation
- Pain
- Numbness
Narrative
Description of Event or Problem
MY GUMS WERE THOROUGHLY NUMB, AND I FELT NO MOUTH PAIN WHATSOEVER. HOWEVER, I HAD EXCRUCIATING, SHOOTING HEADACHE PAIN IN THE RIGHT OCCIPITAL AREA OF MY HEAD AS MY DOCTOR BEGAN SCREWING IN THE DEVICE. IT FELT AS IF SHE WAS SCREWING EACH APPLIANCE INTO MY BRAIN. THE PAIN WORSENED WITH EACH SCREW, AND THE PAIN SPREAD ACROSS BOTH SIDES AND BEHIND MY EYES. AFTER THE INSTALL, WHILE MY GUMS AND JAW WAS PAIN FREE, I WAS IN TEARS, HYPERVENTILATING, AND FEELING LIKE I WAS ABOUT TO THROW UP FROM THE PAIN. IT TOOK 45 MINS TO RECOVER ENOUGH TO LEAVE THE OFFICE. FRANKLY, THIS WAS ON PAR WITH MY WORST LABOR PAIN! I AM TYPICALLY VERY TOUGH AND HAVE NO PROBLEM WITH PROCEDURES. THE DOCTOR SAID SHE HAD NEVER HEARD ABOUT THIS HAPPENING, AND COULDN'T THINK OF A VIABLE REASON FOR THE HEADACHE PAIN. THIS WAS ABOUT 36 HOURS AGO, AND DESPITE TAKING (B)(6), I AM STILL SUFFERING FROM HEADACHE PAIN. MY GUMS ARE STILL SORE, BUT NOTHING SIGNIFICANT. I WAS CONTACTED BY DEVICE REP AND HE SAID NO EFFECTS LIKE THIS REPORTED. I WANT TO MAKE SURE THERE IS A RECORD.