MAUDE Adverse Event Report: SENSODYNE DEEP CLEAN TOOTHBRUSH; TOOTHBRUSHES

Device Problem Product Quality Problem (1506)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Bristles came loose and is stuck in my throat foreign body in throat bristles came loose and is stuck in my throat foreign body ingestion case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in throat in a patient who received haleon toothbrush (sensodyne deep clean toothbrush) toothbrush (batch number unk, expiry date unknown) for drug use for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started sensodyne deep clean toothbrush.On an unknown date, an unknown time after starting sensodyne deep clean toothbrush, the patient experienced foreign body in throat (serious criteria haleon medically significant) and foreign body ingestion.On an unknown date, the patient experienced product complaint.The action taken with sensodyne deep clean toothbrush was unknown.On an unknown date, the outcome of the foreign body in throat and foreign body ingestion were unknown and the outcome of the product complaint was unknown.The reporter considered the foreign body in throat and foreign body ingestion to be related to sensodyne deep clean toothbrush.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the adverse event information was received from consumer via call center representative (email) on (b)(6) 2024 and consumer reported that"i went to use the sensodyne toothbrush and one of the bristles came loose and now is stuck in my throat.It feels like i have a fishbone stuck in my throat.It is very horrible.I can't get it out because it's too deep and it doesn't go down with water either.Attached images".Follow up information was received on 20mar2024 from qa department regarding complaint (b)(4) for lot number unknown.Investigation evaluation: complaint : filaments (bristles) falling out during use filaments get loose during use filaments get stuck in my teeth / braces haleon code: cpc loose brist evaluation: check if the duration of use of the brush is known or approximately known.Check if brush is (heavily) used.Overall appearance (spread filaments, scratches on the backside of the brush head, toothpaste residue between tufts of bristles and in grooves of handle) as well as smell of toothpaste flavor are indicators.Sometimes, squeeze or bite marks can be seen on the filaments.Response to consumer (if applicable): this complaint has been investigated by our quality department and no conditions were discovered within our processes which would have caused or contributed to the reported event.Applying too much pressure during brushing or too long usage of brush may cause this type of defect.The investigation report concluded the complaint as an inconclusive.The pqc number was reported as (b)(4).Initial and follow up processed together.

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: SENSODYNE DEEP CLEAN TOOTHBRUSH
• Type of Device: TOOTHBRUSHES
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059
• MDR Report Key: 18976968
• MDR Text Key: 338547496
• Report Number: 9615008-2024-00005
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other