MAUDE Adverse Event Report: COLGATE SANXIAO CO., LTD. COLGATE TOOTHBRUSH 360 UNSPECIFIED; MANUAL TOOTHBRUSH

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Sticking (1597)

Patient Problems Discomfort (2330); Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

Initial information was received on (b)(6) 2015 from a consumer.This female consumer used colgate 360 manual toothbrush and the bristles fell out and became stuck in her throat, gums and tongue.She began using the toothbrush on an unknown date (frequency not specified).Subsequently, she experienced the events on an unknown date in 2015.A dentist was consulted and removed same of the bristles.However, one bristle remained stuck in her throat and could not be removed which caused her discomfort.At the time of this report, the action taken with the toothbrush was unknown and the consumer continued to experience discomfort due to having a bristle stuck in her throat.(b)(4).

• Brand Name: COLGATE TOOTHBRUSH 360 UNSPECIFIED
• Type of Device: MANUAL TOOTHBRUSH
• Manufacturer (Section D): COLGATE SANXIAO CO., LTD.; no.1 , sanxiao road; yangzhou, jiangsu 2251 11; CH 225111
• Manufacturer (Section G): COLGATE SANXIAO CO., LTD.; no.1 , sanxiao road; yangzhou, jiangsu 2251 11; CH 225111
• Manufacturer Contact: no.1 , sanxiao road; yangzhou, jiangsu 22511-1 ; 8787930
• MDR Report Key: 4562088
• MDR Text Key: 5477253
• Report Number: 3003205012-2015-00003
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• PMA/PMN Number: 8726855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/10/2015

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?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 02/25/2015
• 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): Required Intervention