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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. GUM - 1775R PERIOSHIELD ORAL HEALTH RINSE, 10 OUNCE BOTTLE; RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)
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SUNSTAR AMERICAS, INC. GUM - 1775R PERIOSHIELD ORAL HEALTH RINSE, 10 OUNCE BOTTLE; RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS) Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Chest Pain (1776); Hypoxia (1918); Cough (4457); Unspecified Respiratory Problem (4464)
Event Date 04/26/2021
Event Type  Injury  
Event Description
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.
 
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Brand Name
GUM - 1775R PERIOSHIELD ORAL HEALTH RINSE, 10 OUNCE BOTTLE
Type of Device
RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)
Manufacturer (Section D)
SUNSTAR AMERICAS, INC.
MDR Report Key12092501
MDR Text Key259357872
Report NumberMW5102204
Device Sequence Number1
Product Code NTO
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 06/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/29/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age97 YR
Patient Weight39
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