MAUDE Adverse Event Report: SUNSTAR INC PROXABRUSH; INTERDENTAL BRUSH

Model Number UNKNOWN

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

Patient Problem Inflammation (1932)

Event Date 02/16/2024

Event Type  Injury  

Event Description

Customer states that after utilizing the proxabrush interdental brush, the wire nicked her gum causing an infection in their gums.The infection needed to be treated at the hospital with iv antibiotics, oral mouth rinse and prescription antibiotics issued.The individual was not admitted to the hospital but was treated and released from the er.The individual reported swelling on the right side of her cheek, limited mouth movement due to pain and difficulties eating solid foods.The individual was at the dentist 2 days prior to the reported event.The individual was unable to identify the exact product type utilized.

• Brand Name: PROXABRUSH
• Type of Device: INTERDENTAL BRUSH
• Manufacturer (Section D): SUNSTAR INC; 301 e. central rd; schaumburg IL 60195
• Manufacturer (Section G): SUNSTAR AMERICAS INC; 301 e. central; schaumburg IL 60195
• Manufacturer Contact: paula wendland ; 301 e. central; schaumburg, IL 60195 ; 7733554024
• MDR Report Key: 18912708
• MDR Text Key: 337763092
• Report Number: 1413787-2024-00099
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• PMA/PMN Number: K974761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/06/2024
• Date Manufacturer Received: 03/06/2024
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic