GUM - 1775R PERIOSHIELD ORAL HEALTH RINSE, 10 OUNCE BOTTLE
Received Jun 29, 2021 · Event occurred Apr 26, 2021
Report MW5102204 · MDR key 12092501
Device
Generic name
Rinse, Oral, Antibacterial (by Physical Means)
Product problems
- Patient-Device Incompatibility
Patient
97 YR
- Chest Pain
- Hypoxia
- Cough
- Unspecified Respiratory Problem
- Chest Pain
- Hypoxia
- Cough
- Unspecified Respiratory Problem
Narrative
Description of Event or Problem
I ORDERED THIS GUM PERIOSHIELD ON (B)(6) 2020 FROM (B)(6) AS PART OF A CHRISTMAS GIFT FOR MY (B)(6) YEAR OLD MOM. SHE USED THE MOUTHWASH UP UNTIL (B)(6) AND THEN START TO COMPLAIN ABOUT NOT HAVING ENOUGH OXYGEN. WE THOUGHT HER O2 MACHINE WAS MALFUNCTIONING AND REPLACED IT. THE PROBLEM CONTINUED AND ON (B)(6) 2021, SHE WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF ACUTE HYPOXEMIC RESPIRATORY FAILURE; DYSPNEA, COUGH, CHEST TIGHTNESS. O2 SAT 83% ON ROOM AIR. DRY COUGH IN TRIAGE. 95% ON 3L. SHE WAS DISCHARGED ON (B)(6) 2021. SHE HAD COPD PRIOR TO THIS AND IS VULNERABLE TO CHEST/BREATHING RELATED ILLNESSES. ABOUT 30 TESTS WERE PERFORMED DURING HER HOSPITAL STAY. I DON'T KNOW WHICH ONES TO HIGHLIGHT. NOW FEEL THAT THIS MOUTHWASH CONTRIBUTED TO THE PROBLEM.