MAUDE Adverse Event Report: M AND C SCHIFFER GMBH SENSODYNE TOOTHBRUSH; TOOTHBRUSHES

Device Problem Product Quality Problem (1506)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

One got stuck in my throat/ like a fish bone/ took a long time to dislodge [foreign body in throat].Shed their bristles/sticking in my teeth [foreign body in mouth].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 gsk toothbrush (sensodyne toothbrush) toothbrush for oral hygiene.This case was associated with a product complaint.On an unknown date, the patient started sensodyne toothbrush.On an unknown date, an unknown time after starting sensodyne toothbrush, the patient experienced foreign body in throat (serious criteria gsk medically significant), foreign body in mouth and product complaint.The action taken with sensodyne toothbrush was unknown.On an unknown date, the outcome of the foreign body in throat, foreign body in mouth and product complaint were unknown.It was unknown if the reporter considered the foreign body in throat and foreign body in mouth to be related to sensodyne toothbrush.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: the adverse event information was received on 24 jun 2021 from a consumer via call center representative (email).The consumer reported "i usually buy my toothbrush serial number (b)(4) in batches of four, three times a year.They have been a favorite of mine for a long time because of the gum and tongue cleaner on the back, which helps keep my mouth clean and healthy.However, three of the last four have shed their bristles during cleaning.This resulted in them sticking in my teeth.Unfortunately, one got stuck in my throat, like a fish bone.This was very distressing and took a long time to dislodge.I would really like to continue using this brush, how can i guarantee this won't happen again? looking forward to hearing from you." follow up information was received on 24 jun 2021 from quality assurance (qa) department regarding complaint (b)(4) (issue number) and pqc92616 (pqc number) for lot number unknown.Complaint conclusion: complaint inconclusive pqc evaluation: no sample was returned for this complaint and the lot/batch details were not received so a full investigation cannot be completed.As this information is not available the complaint cannot be substantiated and will be closed as inconclusive.If the consumer contacts us with additional information or if the complaint sample is received, the complaint issue will be reopened and further evaluated.All of the documentation pertinent to a specific lot of finished product is contained in a [?]batch envelope'.Prior to the disposition of the product, the contents of each batch envelope is reviewed; approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing.This review also verifies that all test results meet specification requirements.Initial and follow-up information processed together.

• Brand Name: SENSODYNE TOOTHBRUSH
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): M AND C SCHIFFER GMBH; neustadt/weid,, ; GM
• MDR Report Key: 12174646
• MDR Text Key: 273309205
• Report Number: 9615008-2021-00018
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• 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: 06/24/2021
• 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