MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. PERIOSHIELD ORAL RINSE

Model Number 1775R

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Dyspnea (1816); Hypoxia (1918); Respiratory Failure (2484); Cough (4457)

Event Date 04/26/2021

Event Type  Injury  

Event Description

I ordered this gum perioshiled as part of a christmas gift for my mom.She used the mouthwash and then start to complain about not having enough oxygen.We thought her o2 machine was malfunctioning and replaced it.The problem continued.She was admitted to the hospital with a diagnosis of acute hypoxemic respiratory failure, dyspnea, cough, chest tightness.O2 sat level of 83% on room air.Dry cough in triage 95% on 3l.She was discharged.She had copd prior to this and is vulnerable to chest/breathing related illness.About 30 tests were performed during her stay.I don't know which ones to highlight.Now feel this mouthwash contributed to the problem.Hospitalized for 8 days.

• Brand Name: PERIOSHIELD ORAL RINSE
• Type of Device: ORAL RINSE
• Manufacturer (Section D): SUNSTAR AMERICAS, INC.; 301 east central road; schaumburg IL 60195
• Manufacturer (Section G): SUNSTAR AMERICAS, INC.; 301 e. central road; schaumburg IL 60195
• Manufacturer Contact: deanna anderson ; 301 east central road; schaumburg, IL 60195
• MDR Report Key: 12849362
• MDR Text Key: 281070929
• Report Number: 0001413787-2021-00013
• Device Sequence Number: 1
• Product Code: NTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/27/2021

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: Lay User/Patient
• Device Model Number: 1775R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; BUDESONIDE-FORMOTEROL; CALCIUM SUPPLEMENT; CARVEDILOL; FAMOTIDINE; IPRATROPIUM; ISOSORBIDE MONONITRATE; PREDNISONE; SPIRIVA HANDIHALER
• Patient Outcome(s): Hospitalization
• Patient Age: 97 YR
• Patient Sex: Female
• Patient Weight: 39 KG
• Patient Race: Black Or African American