MalfunctionNTO
GUM PERIOSHIELD ORAL HEALTH RINSE
Received Jun 21, 2021 · Event occurred Jun 17, 2021
Report MW5102010 · MDR key 12040574
Device
Generic name
Rinse, Oral, Antibacterial (by Physical Means)
Product problems
- Patient-Device Incompatibility
Patient
44 YR
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
NOTIFIED BY (B)(6) THAT I HAD PURCHASED MOUTHWASH CONTAMINATED WITH BURKHOLDERIA CEPACIA. I DON'T KNOW IF I AM SUFFERING ADVERSE EFFECTS. I DID HAVE A CUT IN MY GUM AND IT HAS BEEN IRRITATED WHILE USING THIS PRODUCT. GUM - 1775R PERIOSHIELD ORAL HEALTH RINSE, 10 OUNCE BOTTLE GUM HAS INFORMED US THAT THE PRODUCT MAY BE CONTAMINATED WITH MICRO-ORGANISMS BURKHOLDERIA CEPACIA. I RECEIVED A NOTICE TO FILE A REPORT.