MAUDE Adverse Event Report: SHUMEI INDUSTRIAL (HEBEI) CO LTD SHUMITECT TOOTHBRUSH; TOOTHBRUSHES

Lot Number M0228H

Device Problem Product Quality Problem (1506)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Pharyngeal injury.This case was reported by a non-health professional via (b)(6) representative and described the occurrence of pharyngeal injury in a female patient who received gsk toothbrush ((b)(6) toothbrush) toothbrush for an unknown indication.On an unknown date, the patient started (b)(6) toothbrush.On an unknown date, an unknown time after starting (b)(6) toothbrush, the patient experienced pharyngeal injury (serious criteria gsk medically significant) and product quality issue.On an unknown date, the outcome of the pharyngeal injury and product quality issue were unknown.It was unknown if the reporter considered the pharyngeal injury to be related to (b)(6) toothbrush.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.On an unknown date, the patient started using (b)(6) toothbrush (for gentle periodontal care, slim, regular head (gm2)).On an unknown date, when the patient was using the toothbrush, its bristles came off and left in the mouth.On an unknown date, when the patient was using the toothbrush for the second time, its bristles came off and stuck on the throat (serious criteria gsk medically significant).Follow-up information received on 9 february 2021.The toothbrush had been received.The lot number was identified as m0228h.No further information is expected.Additional details: global product description: sensodyne gum care regular medium toothbrush 1ct primary package lot number: m0228.On (b)(6) 2021 09:22:00: immediate analysis has been conducted upon receiving the returned sample.The toothbrush has been used, and all the bristles tufting holes are having anchor wires.No filament detach after few times of manually pressing and rubbing against the bristles by finger thumb.After further reviewed the complaint history, no similar complaint of this batch product has been fed back.Further appearance checked under magnifier also shows all bristles are in good condition, no any damaged is found.Physical checked on the returned sample, the bristles retention force ( spec: > or = to 20n, test result: 30.0n, 31.2n, 27.6n ) anchor wire length( spec: 2.3+0.1/-0.05mm, test result: 2.30 mm, 2.32mm, 2.32mm) number of filaments in each tufts (spec: 40 ± 4, test result: 42,40,42) are all within the product specifications.No abnormality can be identified for the complained product from investigation results.The defect may be caused by filament get stuck in-between teeth or between teeth and bracket/dental brace in using and then pulled out.Not related to manufacturing process.;(b)(6) 2021 11:59:00: immediate analysis has been conducted upon receiving the returned sample.The toothbrush has been used, and all the bristles tufting holes are having anchor wires.No filament detach after few times of manually pressing and rubbing against the bristles by finger thumb.After further reviewed the complaint history, no similar complaint of this batch product has been fed back.Further appearance checked under magnifier also shows all bristles are in good condition, no any damaged is found.Physical checked on the returned sample, the bristles retention force ( spec: > or = to 20n, test result: 30.0n, 31.2n, 27.6n ) anchor wire length (spec: 2.3+0.1/-0.05mm, test result: 2.30 mm, 2.32mm,2.32mm) number of filaments in each tufts (spec: 40 ± 4, test result: 42,40,42) are all within the product specifications.No abnormality can be identified for the complained product from investigation results.The defect may be caused by filament get stuck in-between teeth or between teeth and bracket/dental brace in using and then pulled out.Not related to manufacturing process.; complaint conclusion: unsubstantiated.

• Brand Name: SHUMITECT TOOTHBRUSH
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): SHUMEI INDUSTRIAL (HEBEI) CO LTD; zhou city; CH
• Manufacturer Contact: po box 13398; research triangle park; 8888255249
• MDR Report Key: 11397977
• MDR Text Key: 245593513
• Report Number: 3006536571-2021-00001
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: M0228H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other