inforMED
InjuryNTO

PERIOSHIELD ORAL RINSE

Received Nov 19, 2021 · Event occurred Jan 4, 2021

Report 0001413787-2021-00014 · MDR key 12849386

Device

Generic name

Oral Rinse

Model number

1775R

Lot number

02A, 01A, AND 02Z

Product problems

  • Nonstandard Device
  • Patient-Device Incompatibility

Patient

72 YR · Male

  • Rash
  • Skin Infection
  • Rash
  • Skin Infection

Narrative

Description of Event or Problem

CUSTOMER STATED HE USED PRODUCT WITH HIS FACE MASK AND IT INFECTED HIS SKIN AROUND HIS MOUTH HE STARTED TO GET SORES. HE HAD BEEN USING THE PRODUCT FOR ABOUT A YEAR AS A RECOMMENDATION FORM HIS DENTIST. SO STARTED USE AROUND (B)(6) 2020. AND NOTICED HE STARTED GETTING SORES AROUND THE OUTSIDE OF HIS MOUTH IN (B)(6) 2021. HE THEN WENT TO HIS DOCTOR FOR MEDICAL ATTENTION. DOCTOR GAVE HIM A STEROID CREAM MEDICATION FOR THE INFECTION AS HE COULD NOT FIND OUT WHY HE WAS GETTING SORES AROUND THE OUTSIDE OF HIS MOUTH. HE DID NOT TELL THE DOCTOR HE WAS USING OUR PERIOSHEILD. THEN HE WENT BACK TO THE DOCTOR IN (B)(6) 2021 AS THE SORES WERE NOT GOING AWAY. DOCTOR THEN GAVE HIM A DIFFERENT STEROID CREAM TO USE. SORES STILL DID NOT GO AWAY. HE THEN GOT THE RECALL LETTER ABOUT PERIOSHIELD ON (B)(6) 2021 AND WENT BACK TO DOCTOR. DOCTOR THEN TOLD HIM TO DISCONTINUE THE USE OF THE PERIOSHIELD RIGHT AWAY. THE SORES THEN STARTED TO GO AWAY AFTER A WEEK OF NOT USING THE PERIOSHIELD.

Description of Event or Problem

CUSTOMER STATED HE USED PRODUCT WITH HIS FACE MASK AND IT INFECTED HIS SKIN AROUND HIS MOUTH HE STARTED TO GET SOARS. HE HAD BEEN USING THE PRODUCT FOR ABOUT A YEAR AS A RECOMMENDATION FORM HIS DENTIST. SO STARTED USE AROUND (B)(6) 2020. AND NOTICED HE STARTED GETTING SOARS AROUND THE OUTSIDE OF HIS MOUTH IN (B)(6) 2021. HE THEN WENT TO HIS DOCTOR FOR MEDICAL ATTENTION. DOCTOR GAVE HIM A STEROID CREAM MEDICATION FOR THE INFECTION AS HE COULD NOT FIND OUT WHY HE WAS GETTING SOARS AROUND THE OUTSIDE OF HIS MOUTH. HE DID NOT TELL THE DOCTOR HE WAS USING OUR PERIOSHEILD. THEN HE WENT BACK TO THE DOCTOR IN (B)(6) 2021 AS THE SOARS WERE NOT GOING AWAY. DOCTOR THEN GAVE HIM A DIFFERENT STEROID CREAM TO USE. SOARS STILL DID NOT GO AWAY. HE THEN GOT THE RECALL LETTER ABOUT PERIOSHIELD ON (B)(6) 2021 AND WENT BACK TO DOCTOR. DOCTOR THEN TOLD HIM TO DISCONTINUE THE USE OF THE PERIOSHIELD RIGHT AWAY. THE SOARS THEN STARTED TO GO AWAY AFTER A WEEK OF NOT USING THE PERIOSHIELD.

Remedial action

  • Recall