GUM(R) PERIOSHIELD ORAL HEALTH RINSE 300 ML (10 FL. OZ.) BLUE BOTTLES
Received Jun 16, 2021 · Event occurred Jun 1, 2021
Report MW5101956 · MDR key 12016740
Device
Generic name
Rinse, Oral, Antibacterial (by Physical Means)
Lot number
01A
Product problems
- Nonstandard Device
Patient
44 YR
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
I RECEIVED A LETTER IN THE MAIL DATED (B)(6) 2021 REGARDING SUNSTAR AMERICAS INC (SAI), GUM PERIOSHIELD ORAL HEALTH RINSE. I WAS NOT ABLE TO FIND THAT RECALL LETTER IN YOUR INVENTORY BUT DID FIND THAT ANOTHER PRODUCT FROM SUNSTAR WITH THE SAME MICROORGANISM (BURKHOLDERIA CEPACIA OR CONTAMINANTS) WAS PREVIOUSLY RECALLED, SO I AM SUBMITTING MY RESPONSE FORM HERE. I PURCHASED A TOTAL OF 10 BOTTLES OF THE PRODUCT IN QUESTION, WITH 6 REMAINING UNUSED AND ONE PARTIALLY USED. THE PRODUCT IS IN A BLUE BOTTLE.