inforMED
InjuryJEP

AGGA DENTAL DEVICE

Received Apr 10, 2023 · Event occurred Mar 13, 2023

Report MW5116516 · MDR key 16714294

Device

Generic name

Retainer, Matrix

Manufacturer

Unk

Product problems

  • Inadequacy of Device Shape and/or Size

Patient

28 YR · Female

  • Headache
  • Hemorrhage/Blood Loss/Bleeding
  • Failure of Implant
  • Pain
  • Sensitivity of Teeth
  • Headache
  • Hemorrhage/Blood Loss/Bleeding
  • Failure of Implant
  • Pain
  • Sensitivity of Teeth

Narrative

Description of Event or Problem

I WAS FIT FOR AN AGGA APPLIANCE BY MY DENTIST. I ONLY HAD THE BOTTOM PLACED FIRST FOR ABOUT A WEEK, THEN THE TOP. I HAD INTENSE PAIN, GUM IRRITATION, MIGRAINES, AND STARTED FINALLY SPITTING UP BLOOD AT RANDOM TIMES. THIS WAS BRIGHT RED BLOOD LEAKING OUT OF MY GUMS AT RANDOM TIMES. ALL OF A SUDDEN I COULD FEEL A WARM SENSATION AND WOULD SPIT BRIGHT RED BLOOD MULTIPLE TIMES PER DAY. I FINALLY DEMANDED THE DEVICE BE REMOVED FROM MY TEETH. I STILL HAVE CEMENT ALL OVER MY TEETH AFTER GETTING IT OFF OVER 3 WEEKS AGO AND PAIN IN MY RIGHT SIDE MOUTH TOP TEETH.