MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. GUM PROXABRUSH WIDE; TOOTHBRUSH, MANUAL

Model Number	GUM WIDE PROXABRUSH
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Inflammation (1932)
Date of Event	09/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer had stated she has never used the interdental products before.She had used the proxabrush on (b)(6) 2023 before she had dinner and said she felt a little something in her mouth.After dinner she used the product again and noticed she was having an allergic reaction.Her gums started to turn red and had very bad burning feeling.She swished with baking soda and water and took some benadryl.She still has a little burning feeling on her gums after the benadryl.She did not seek medical treatment.She is allergic to rubber.

• Brand Name: GUM PROXABRUSH WIDE
• Common Device Name: TOOTHBRUSH, MANUAL
• Manufacturer (Section D): SUNSTAR AMERICAS, INC.; 301 east central road; schaumburg IL 60195
• Manufacturer (Section G): SUNSTAR AMERICAS INC.; 301 east central road; schaumburg 60195
• Manufacturer Contact: monica jadczak ; 301 east central road; schaumburg, IL 60195 ; 8477944229
• MDR Report Key: 17873023
• Report Number: 1413787-2023-00071
• Device Sequence Number: 7490454
• Product Code: EFW
• UDI-Device Identifier: 00070942002479
• UDI-Public: 00070942002479
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: GUM WIDE PROXABRUSH
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female