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

Model Number 3614FC

Device Problem Break (1069)

Patient Problems Post Traumatic Wound Infection (2447); Needle Stick/Puncture (2462)

Event Date 02/10/2020

Event Type  Injury  

Event Description

Consumer had purchased the proxabrush go-betweens and the very first time she had used the brush, it came off and poked her in the gum.She then had an infection.When she pushed it in and pulled it out, the brush was off the handle and on her tongue.She went to the doctor and got antibiotics.

Manufacturer Narrative

This mdr report is generated retrospectively based on complaints audit.

• Brand Name: GUM PROXABRUSH GO-BETWEENS WIDE
• Type of Device: 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 IL 60195
• Manufacturer Contact: cynthia culmo ; 301 east central road; schaumburg, IL 60195 ; 8477944241
• MDR Report Key: 15116416
• MDR Text Key: 296749693
• Report Number: 0001413787-2022-00215
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 3614FC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other
• Patient Sex: Female