MAUDE Adverse Event Report: COLGATE SANXIAO CO., LTD. ELMEX CHILDREN'S TOOTHBRUSH; MANUAL TOOTHBRUSH

Device Problem Component Falling (1105)

Patient Problem Vomiting (2144)

Event Date 01/15/2014

Event Type  Injury  

Event Description

Initial info was received on (b)(6) 2014 from a consumer's mother.This (b)(6) year old female consumer used (b)(4) children's toothbrush and experienced vomiting after one of the bristles fell out and "stacked vertically in her throat".She began using the toothbrush on (b)(6) 2014, brushing once daily.Subsequently, on (b)(6) 2015, one of the bristles fell out and was "stacked vertically in the throat:".The consumer's mother tried to remove the bristle unsuccessfully with a tool, which caused the child to vomit.On an unk date in (b)(6) 2014, the consumer was seen in the hospital where an ears, nose and throat (ent) physician removed the bristle with a pair of "pinchers" and administered an unspecified spray as treatment.Use of the toothbrush was discontinued on (b)(6) 2014.At the time of the report, the outcomes of the events were resolved.(b)(4).

• Brand Name: ELMEX CHILDREN'S TOOTHBRUSH
• 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 ; CH
• Manufacturer Contact: no.1 , sanxiao road; yangzhou, jiangsu
• MDR Report Key: 3644856
• MDR Text Key: 4350171
• Report Number: 3003205012-2014-00021
• 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: 01/27/2014

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: 01/27/2014
• Initial Date FDA Received: 01/31/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 3 YR
• Patient Weight: 15