MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. GUM PERIOSHEILD ORAL HEALTH RINSE 10 OUNCE BOTTLE; RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)

Lot Number 01A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Dyspnea (1816); Fever (1858); Pneumonia (2011); Low Oxygen Saturation (2477)

Event Date 06/06/2021

Event Type  Injury  

Event Description

Mother had trouble breathing and fever.She was taken by ambulance to the hospital and tested positive for streptococcus caused by mouth-type bacteria.Diagnosed with pneumonia and low oxygen.Doctors opened a pick-line for antibiotics due to weakened veins.She was in the hospital for 8 days and transfer to a nursing facility where she is continuing antibiotic treatment for 4 to 6 weeks longer.Outcome still unknown.

• Brand Name: GUM PERIOSHEILD ORAL HEALTH RINSE 10 OUNCE BOTTLE
• Type of Device: RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)
• Manufacturer (Section D): SUNSTAR AMERICAS, INC.
• MDR Report Key: 12016693
• MDR Text Key: 257430613
• Report Number: MW5101952
• Device Sequence Number: 1
• Product Code: NTO
• UDI-Device Identifier: 00070942304818
• UDI-Public: 070942304818
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/15/2021

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
• Device Lot Number: 01A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 106