MAUDE Adverse Event Report: SHUMEI INDUSTRIAL (HEBEI) CO LTD SHUMITECT YASASHIKU PERIODONTAL DISEASE REGULAR TOOTHBRUSH NORMAL; TOOTHBRUSHES

Device Problem Product Quality Problem (1506)

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

Event Date 08/11/2021

Event Type  Injury  

Event Description

Foreign body in throat [foreign body in throat].Case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in throat in a (b)(6) male patient who received gsk toothbrush (shumitect yasashiku periodontal disease regular toothbrush normal) toothbrush for oral hygiene.On (b)(6) 2021, the patient started shumitect yasashiku periodontal disease regular toothbrush normal.On (b)(6) 2021, an unknown time after starting shumitect yasashiku periodontal disease regular toothbrush normal, the patient experienced foreign body in throat (serious criteria gsk medically significant) and product quality issue.On an unknown date, the outcome of the foreign body in throat and product quality issue were unknown.It was unknown if the reporter considered the foreign body in throat to be related to shumitect yasashiku periodontal disease regular toothbrush normal.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.[clinical course]: on (b)(6) 2021, the patient started using shumitect yasashiku periodontal disease regular toothbrush normal.A bristle that had fallen off was stuck in the throat (serious criteria gsk medically significant).While he was brushing his teeth with the toothbrush, 2 bristles fell off.He was able to remove one of the bristles, but the other was still stuck in the throat.It could not be removed even by gargling.No further information is expected.Follow-up information received on 20 august 2021 additional details: [summary of investigation] case number: (b)(4).Related interaction: (b)(4).Global product description: sensodyne gum care regular medium toothbrush 1ct.Primary package lot number: unk 02493784.Investigation evaluation: 2021-08-20 08:55:59: no defect sample or batch code or pictures available for confirmation and investigation.Base on the customer complaint history of this toothbrush and investigation against all the previous returned samples, filament came off defect was caused in the following conditions: improper use of toothbrush, on some returned sample, obvious similar pinch marks are found on the bristles, the defect may be caused by filament get stuck in-between teeth or between teeth and bracket/dental brace and then pulled out.From the perspective of the process, it cannot be completely ruled out that insufficient number of filaments in the hole in manufacturing process leads to the filament fall off during use.In jul 2019, f or all the tufting machines in the workshop, sensors have been installed to the filament feeder to automatically detect whether there is insufficient filament.When the filament is close to the limit position, the sensors will automatically alarm to remind the operators to replenish the filament in time.For the complaint contains no valid information to initiate an investigation, thus this complaint will be closed as inconclusive temporarily and the complaint will be re-opened when the defect sample is acquired.; complaint conclusion: complaint inconclusive investigation completion date: 2021-08-20 08:56:00 case number: (b)(4).Related interaction: (b)(4).Global product description: sensodyne gum care regular medium toothbrush 1ct.Primary package lot number: unk 02493784.Investigation evaluation: 2021-08-20 08:55:59: no defect sample or batch code or pictures available for confirmation and investigation.Base on the customer complaint history of this toothbrush and investigation against all the previous returned samples, filament came off defect was caused in the following conditions: improper use of toothbrush, on some returned sample, obvious similar pinch marks are found on the bristles, the defect may be caused by filament get stuck in-between teeth or between teeth and bracket/dental brace and then pulled out.From the perspective of the process, it cannot be completely ruled out that insufficient number of filaments in the hole in manufacturing process leads to the filament fall off during use.In jul 2019, f or all the tufting machines in the workshop, sensors have been installed to the filament feeder to automatically detect whether there is insufficient filament.When the filament is close to the limit position, the sensors will automatically alarm to remind the operators to replenish the filament in time.For the complaint contains no valid information to initiate an investigation, thus this complaint will be closed as inconclusive temporarily and the complaint will be re-opened when the defect sample is acquired.; complaint conclusion: complaint inconclusive.

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: SHUMITECT YASASHIKU PERIODONTAL DISEASE REGULAR TOOTHBRUSH NORMAL
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): SHUMEI INDUSTRIAL (HEBEI) CO LTD; zhou city, ; CH
• MDR Report Key: 12406442
• MDR Text Key: 280547574
• Report Number: 3006536571-2021-00005
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• 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
• Patient Age: 51 YR