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

Model Number 1775P

Device Problem Nonstandard Device (1420)

Patient Problem Unspecified Infection (1930)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

This is a recall product.

Event Description

Patient used product after having their tooth pulled in (b)(6) 2021 and experienced severe infection in their jaw.Patient has been on antibiotics for about 3 months and has been hospitalized twice.

• Brand Name: PERIOSHIELD ORAL RINSE
• Type of Device: ORAL RINSE
• Manufacturer (Section D): SUNSTAR AMERICAS, INC.; 301 e central road; schaumburg 60195
• MDR Report Key: 12172530
• MDR Text Key: 261674868
• Report Number: 1413787-2021-00011
• Device Sequence Number: 1
• Product Code: NTO
• Combination Product (y/n): N
• PMA/PMN Number: K053166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 06/30/2021

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 Expiration Date: 11/30/2022
• Device Model Number: 1775P
• Device Lot Number: 04Z
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/15/2021
• 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: DAILY ANTIBIOTICS (VERBATIM)
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 73