MAUDE Adverse Event Report: SUNSTAR AMERICAS INC. GUM TECHNIQUE SENSITIVE CLEAN ULTRA SOFT TOOTHBRUSH; TOOTHBRUSH, MANUAL

Model Number 528A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Choking (2464); Device Embedded In Tissue or Plaque (3165)

Event Date 12/05/2022

Event Type  malfunction  

Event Description

Consumer stated she was using the gum sensitive clean toothbrush and lately while using the toothbrush it has caused her to gag and choke on the bristles, due to them shedding in her mouth while brushing.It also caused the bristles to get caught down her throat.

• Brand Name: GUM TECHNIQUE SENSITIVE CLEAN ULTRA SOFT TOOTHBRUSH
• 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: monica jadczak ; 301 east central road; schaumburg, IL 60195 ; 8477944229
• MDR Report Key: 16085790
• MDR Text Key: 306521545
• Report Number: 0001413787-2022-00350
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A#S-P#N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 528A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2022
• 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
• Patient Sex: Female