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

Catalog Number 1775R

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2021

Event Type  malfunction  

Event Description

An urgent recall medical device recall was issued.I, the customer was notified by (b)(6) on (b)(6) 2021.The reason for the recall stated in the letter was that the product could have been contaminated with micro-organisms burkholderia cepacia and/or burkholderia contaminants.I have not used the product since around (b)(6) 2021.Fda safety report id # (b)(4).

• Brand Name: GUM PERIOSHIELD ORAL HEALTH RINSE
• Type of Device: RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)
• Manufacturer (Section D): SUNSTAR AMERICAS, INC.
• MDR Report Key: 12032199
• MDR Text Key: 257483639
• Report Number: MW5101973
• Device Sequence Number: 1
• Product Code: NTO
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 1775R
• Device Lot Number: 01A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 57