MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. SUNSTAR GUM TECH DEEP CLEAN 525 COMP SOFT COMP SOUPLE TOOTHBRUSH; TOOTHBRUSH, MANUAL

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 06/02/2022

Event Type  malfunction  

Event Description

Sunstar gum toothbrush (tech deep clean 525 comp soft) handle failed at joint where hard plastic is joined to elastomer textured section, pic is attached.This has also happened three previous times on three of the same model toothbrush.Fda safety report id# (b)(4).

• Brand Name: SUNSTAR GUM TECH DEEP CLEAN 525 COMP SOFT COMP SOUPLE TOOTHBRUSH
• Type of Device: TOOTHBRUSH, MANUAL
• Manufacturer (Section D): SUNSTAR AMERICAS, INC.
• MDR Report Key: 14696182
• MDR Text Key: 294380941
• Report Number: MW5110334
• Device Sequence Number: 4
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/13/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1