PERIOSHIELD ORAL HEALTH RINSE
Received Jun 28, 2021 · Event occurred Jun 15, 2021
Report MW5102201 · MDR key 12088092
Device
Generic name
Rinse, Oral, Antibacterial (by Physical Means)
Lot number
01Z
Product problems
- Microbial Contamination of Device
Patient
61 YR
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
GUM - 1775R PERIOSHIELD ORAL HEALTH RINSE, 10 OUNCE BOTTLE GUM HAS INFORMED US THAT THE PRODUCT MAY BE CONTAMINATED WITH MICRO-ORGANISMS BURKHOLDERIA CEPACIA.