inforMED
InjuryJEQ

COLGATE 360 OPTIC WHITE BATTERY POWERED TOOTHBRUSH

Received Jun 26, 2015 · Event occurred May 8, 2015

Report 3005607635-2015-00007 · MDR key 4877653

Device

Product problems

  • Microbial Contamination of Device

Patient

37 YR

  • Abscess
  • Pain
  • Swelling

Narrative

Description of Event or Problem

INITIAL INFORMATION WAS RECEIVED ON (B)(6) 2015 FROM A CONSUMER. THIS 37 YEAR OLD FEMALE CONSUMER USED (B)(4) 360 OPTIC WHITE BATTERY POWERED TOOTHBRUSH (LOT #373KE) AND DEVELOPED AN ABSCESS ON HER TOOTH, FACIAL PUFFINESS, AND SHE HAD TWO TEETH BECOME LOOSE. SHE BEGAN USING THE TOOTHBRUSH TWICE A DAY ON AN UNKNOWN DATE IN 2014. THE CONSUMER INDICATED THAT SHE HAS USED THE TOOTHBRUSH FOR A YEAR AND CHANGES THE HEAD OF THE TOOTHBRUSH EVERY THREE MONTHS BUT HAS NEVER CHANGED THE BATTERIES. SHE LAST CHANGED THE HEAD OF HER TOOTHBRUSH APPROXIMATELY SIX WEEKS PRIOR TO THIS REPORT ON (B)(6) 2015. AT THIS TIME, HER TOP BACK TOOTH (NUMBER OF TOOTH UNKNOWN) BECAME LOOSE AND AFTER FOUR VISITS TO A DENTIST WITHIN SIX WEEKS, THE TOOTH WAS EXTRACTED. THE CONSUMER CONTINUED TO USE THE TOOTHBRUSH WITHOUT INCIDENT UNTIL (B)(6) 2015, WHEN SHE NOTICED A TOOTH TO THE BOTTOM BACK OF THE OPPOSITE TOOTH BECAME LOOSE. ON (B)(6) 2015, THE CONSUMER AWOKE WITH FACIAL PUFFINESS AND AN ABSCESS HAD DEVELOPED NEAR THE AFFECTED TOOTH. A DENTAL APPOINTMENT WAS MADE. HOWEVER, THE CONSUMER WENT TO A LOCAL EMERGENCY CARE CENTER TO GET AN ANTIBIOTIC UNTIL SHE COULD SEE HER DENTIST. AT THE EMERGENCY CLINIC, THE CONSUMER RECEIVED AN UNSPECIFIED INJECTION FOR PAIN AND A PRESCRIPTION FOR ORAL PENICILLIN AND IBUPROFEN. NO LAB WORK OR X-RAYS WERE COMPLETED AT THIS TIME. ON THE MORNING OF (B)(6) 2015, THE CONSUMER WET HER TOOTHBRUSH AND SHOOK IT. WHEN SHE DID THIS, "BROWN MOLD" CAME FROM THE TOOTHBRUSH. SHE THOUGHT THE MOLD CAME FROM THE BOTTOM OF THE TOOTHBRUSH BUT WAS UNSURE. THE CONSUMER FELT THE MOLD MAY HAVE CAUSED HER CURRENT SYMPTOMS AND THE LOSS OF HER TOOTH SIX WEEKS AGO. SHE INDICATED THAT SHE HAD NOT SEEN THE "FOREIGN MATTER" UNTIL (B)(6) 2015. THE CONSUMER EXPLAINED THAT WHEN THE TOOTHBRUSH WAS NOT IN USE, IT WAS STORED WITH THE HEAD OF THE TOOTHBRUSH UP LEANING WITHIN A WIRE BASKET WHICH HANGS ON HER BATHROOM WALL. USE OF HEAD OF THE TOOTHBRUSH UP LEANING WITHIN A WIRE BASKET WHICH HANGS ON HER BATHROOM WALL. USE OF THE TOOTHBRUSH WAS DISCONTINUED ON (B)(6) 2015. AT THE TIME OF THIS REPORT, THE EVENTS WERE ONGOING. THIS CASE IS REFERENCED AS (B)(4).