InjuryNTO
GUM PERIO SHIELD ORAL HEALTH RINSE
Received Jun 17, 2021 · Event occurred Jun 7, 2021
Report MW5101968 · MDR key 12032115
Device
Generic name
Rinse, Oral, Antibacterial (by Physical Means)
Lot number
02A
Product problems
- Contamination
- Nonstandard Device
Patient
41 YR
- Dyspnea
- Headache
- Discomfort
- Numbness
- Sensitivity of Teeth
- Hyperresponsive to stimuli
- Dyspnea
- Headache
- Discomfort
- Numbness
- Sensitivity of Teeth
- Hyperresponsive to stimuli
Narrative
Description of Event or Problem
THIS MOUTHWASH HAS CAUSED EXTREME SENSITIVITY TO MY GUMS AND TEETH. I AM UNABLE TO DRINK OR EAT HOT OR COLD ITEMS WITHOUT DISCOMFORT. I HAVE ALSO EXPERIENCED PERIODIC SHORTNESS OF BREATH AND HEADACHES. ADDITIONALLY, THIS PRODUCT CAUSED SEVERE MOUTH NUMBNESS LASTING FOR 2 DAYS EACH TIME. I RECEIVED A RECALL NOTICE STATING THE PRODUCT HAS BEEN CONTAMINATED WITH BURKHOLDERIA CEPACIA AND/OR BURKHOLDERIA CONTAMINANTS FROM THE MANUFACTURER.