inforMED
InjuryNTO

G.U.M. PERIOSHIELD

Received Jun 29, 2021 · Event occurred Jun 14, 2021

Report MW5102209 · MDR key 12092631

Device

Generic name

Rinse, Oral, Antibacterial (by Physical Means)

Product problems

  • Patient-Device Incompatibility

Patient

71 YR

  • Hemorrhage/Blood Loss/Bleeding
  • Unspecified Infection
  • Inflammation
  • Pain
  • Hemorrhage/Blood Loss/Bleeding
  • Unspecified Infection
  • Inflammation
  • Pain

Narrative

Description of Event or Problem

I ORDERED THE PRODUCT, PERIOSHIELD, FROM (B)(6) AND RECEIVED IT ON (B)(6) 2021. I WAS EXPERIENCING BLEEDING GUMS (A PROBLEM I ENCOUNTERED PREVIOUSLY AND WAS TREATED BY MY DENTIST, (B)(6). THIS TIME I DID SOME RESEARCH TO FIND A SIMILAR PRODUCT FROM AN OVER-THE-COUNTER SOURCE AND FOUND SEVERAL POSITIVE REVIEWS ON (B)(6). THE SORENESS AND BLEEDING DID ABATE OVER THE MONTH-PLUS OF USE, AND I RAN OUT OF THE PERIOSHIELD AROUND THE END OF (B)(6). ON (B)(6) 2021 I BEGAN EXPERIENCING PAIN AND SWELLING IN THE AREA OF MY UPPER GUM AREA, ABOVE MY RIGHT FRONT TOOTH. I TRIED TO CALM THE PAIN WITH (B)(6). PAIN PERSISTED, SO I SCHEDULED APPOINTMENT WITH MY DENTIST, DR. (B)(6) ON (B)(6) 2021. HE DIAGNOSED MY PROBLEM AS AN INFECTION IN THE GUM ABOVE FRONT TOOTH #8. THIS IS A FRONT TOOTH WHICH WAS CAPPED MANY YEARS--I'D NEVER HAD PROBLEM WITH IT BEFORE. DR. (B)(6) PRESCRIBED AMOXICILLIN 500MG., THREE PILLS DAILY FOR 7 DAYS. DR. (B)(6) ALSO TOLD ME TO HAVE MY TOOTH EXAMINED BY AN ENDODONTIST TO FURTHER EVALUATE THE PROBLEM. I MADE THE SUGGESTED APPOINTMENT WITH DR. (B)(6) AND SAW HIM ON (B)(6) 2021. HE PERFORMED ANOTHER, MORE DETAILED TYPE OF DENTAL X-RAY. HE ADVISED ME THAT A ROOT CANAL WAS THE BEST METHOD OF TREATMENT, ESPECIALLY IMPORTANT BECAUSE I AM TO HAVE A TOTAL HIP REPLACEMENT LATER THIS SUMMER, AND A ROOT CANAL WAS NECESSARY BECAUSE THE INFECTION WAS IN TISSUE ABOVE THE TOOTH THAT ANTIBIOTICS COULD NOT TOTALLY CLEAR. DR. (B)(6) ASSURED ME THAT A ROOT CANAL WOULD REMOVE ALL THE TISSUE WHERE THE INFECTION HAD SETTLED. THIS WHOLE EVENT HAS COST MORE THAN (B)(6). I BELIEVE THAT THE USE OF THE PRODUCT LED TO THE INFECTION.