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

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Initial info was received on (b)(6), 2015 from a consumer.This female consumer used colgate toothbrush manual and the toothbrush broke while the consumer was cleaning her tongue.She began using the toothbrush on an unk date (frequency not specified).Subsequently, the toothbrush broke on an unk date.No adverse events were reported.At the time of this report, the action taken with the toothbrush was unk.F/u info was received on june 19, 2015 from the consumer.She reported that while scraping her tongue on an unspecified date, the toothbrush broke and she swallowed the brush.On an unk date, an endoscopy was performed to extract date, an endoscopy was performed to extract the brush.The consumer reported that the toothbrush "was inside of me for four months".Add'l info was received on june 26, 2015 from the consumer.The consumer reporter having spent a day in the hospital, to have the brush extracted.At this time, she was nervous and was afraid the event would happen again.Add'l info was received on (b)(6), 2015 from the consumer.She reported that the head of the toothbrush broke while cleaning her tongue like she does everyday.Except this time while cleaning her tongue, the toothbrush broke and she swallowed the head.No further info was reported.This case is referenced as (b)(4).

• Brand Name: COLGATE TOOTHBRUSH MANUAL 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 rd; yangzhou, jiangsu 2251 11; CH 225111
• Manufacturer Contact: no.1 , sanxiao road; yangzhou, jiangsu ; 7328787930
• MDR Report Key: 4944871
• MDR Text Key: 6251713
• Report Number: 3003205012-2015-00010
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• PMA/PMN Number: 872.6855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Type of Report: Initial
• Report Date: 06/01/2015

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 07/27/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention