inforMED
InjuryEMA

WALGREENS LOST FILLING AND LOOSE CAP REPAIR

Received Jan 29, 2019 · Event occurred Nov 19, 2018

Report 3006644229-2019-00002 · MDR key 8286457

Device

Generic name

Cement, Dental

Product problems

  • Appropriate Device Problem Term/Code Not Available

Patient

49 YR

  • Pain
  • Swelling
  • Burning Sensation
  • Pain
  • Swelling
  • Burning Sensation

Narrative

Description of Event or Problem

THIS SERIOUS CASE REPORTS A (B)(6) YEAR OLD MALE USING WALGREENS LOST FILLING & LOOSE CAP REPAIR ON DETERIORATING TEETH. HE HAS A MEDICAL HISTORY OF THROAT AND MOUTH CANCER. HE REPORTED TOOTH DECAY RELATED TO RADIATION AND CHEMOTHERAPY TREATMENTS. ON (B)(6) 2018, THE CONSUMER USED WALGREENS LOST FILLING & LOOSE CAP REPAIR FOR MANAGEMENT OF ONGOING TOOTH DECAY AND EXPERIENCED MOUTH BURNING, BLISTERS IN MOUTH, THROAT SWELLING, PAIN AND SORES IN MOUTH. HE REPORTED USING THIS PRODUCT IN THE PAST FROM WALGREENS AS WELL AS OTHER BRANDS AND DID NOT EXPERIENCE ANY TYPE OF REACTION. THE CONSUMER REPORTED REMOVING THE PRODUCT FROM THE MOUTH. DUE TO THE REACTION TO THIS PRODUCT, HE WAS UNABLE TO EAT FOR A WEEK. HE WAS TAKEN TO A LOCAL EMERGENCY DEPARTMENT TO GET STABILIZED. TREATMENTS REQUIRED TO STABILIZED CONSUMER WERE NOT REPORTED.