MAUDE Adverse Event Report: SHUMEI INDUSTRIAL (HEBEI) CO LTD SENSODYNE DEEP CLEAN SOFT TOOTHBRUSH; TOOTHBRUSHES

Device Problem Product Quality Problem (1506)

Patient Problem Choking (2464)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

First time i get chock when brushing teeth [choking].Case description: this case was reported by a consumer via interactive digital media (facebook) and described the occurrence of choking in a patient who received toothbrush (sensodyne deep clean soft toothbrush) toothbrush (batch number unk, expiry date unknown) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started sensodyne deep clean soft toothbrush.On an unknown date, an unknown time after starting sensodyne deep clean soft toothbrush, the patient experienced choking (serious criteria haleon medically significant) and product complaint.The action taken with sensodyne deep clean soft toothbrush was unknown.On an unknown date, the outcome of the choking and product complaint were unknown.It was unknown if the reporter considered the choking to be related to sensodyne deep clean soft 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: adverse event information was reported by consumer on 20jul2023 via interactive digital media (facebook).The consumer reported that "what happened to your quality control? first time i get chock when brushing teeth.Filaments (bristles) falling out during use filaments get loose during use.Filaments get stuck in my teeth braces." follow-up information was received on 20jul2023 from quality assurance (qa) department regarding complaint(b)(4) and case number(b)(4).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.Complaint was concluded as inconclusive.Follow up information was received by consumer on 20jul2023 via interactive digital media (sprinklr).It was reported that "sku should be sensodyne deep clean soft toothbrush." initial and follow up processed together.

• Brand Name: SENSODYNE DEEP CLEAN SOFT TOOTHBRUSH
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): SHUMEI INDUSTRIAL (HEBEI) CO LTD; zhou city, ; CH
• Manufacturer Contact: 184 liberty corner road, suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 17556608
• MDR Text Key: 321254465
• Report Number: 3006536571-2023-00003
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• 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
• Date Manufacturer Received: 07/20/2023
• 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
• Treatment: NO THERAPY (NO THERAPY) UNKNOWN
• Patient Outcome(s): Other