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

Lot Number S431PAL5376

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Choking (2464)

Event Date 09/23/2022

Event Type  Injury  

Event Description

Made me choked on the toothbrush [choking].Hurt my throat [throat pain].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a patient who received gsk toothbrush (sensodyne toothbrush) toothbrush (batch number s431pal5376, expiry date unknown) for product used for unknown indication.Concurrent medical conditions included sensitivity of gums.In (b)(6) 2022, the patient started sensodyne toothbrush.On (b)(6) 2022, an unknown time after starting sensodyne toothbrush, the patient experienced choking (serious criteria gsk medically significant) and throat pain.The action taken with sensodyne toothbrush was unknown.On an unknown date, the outcome of the choking and throat pain were unknown.The reporter considered the choking and throat pain to be related to sensodyne toothbrush.This report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received from consumer via call center representative (email) on 23sep2022.Consumer reported that "dear sir/madam, yesterday i purchased on of your sensodyne (soft) toothbrushes as i have sensitive gums, whilst using the product today, it lost grip and slipped which made me choked on the toothbrush, i didn't swallow the whole thing (luckily) as i could pull it out of my mouth/throat, however it did scare me half to death and hurt my throat.After this incident i inspected the toothbrush and realised there is actually (next-to) no grip on the brushes handle, i don't understand why this is a thing as toothbrushes should have decent grip to hold as it is something that is going into mouths and going to get wet.I'd like to speak to somebody regarding this incident/issue as this is very dangerous and have just found out.Codes on pack: 060518049 s431pal5376 5 054563 018915.

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: SENSODYNE TOOTHBRUSH
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): M AND C SCHIFFER GMBH; neustadt, weid ; GM
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 15624361
• MDR Text Key: 301916423
• Report Number: 9615008-2022-00008
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: S431PAL5376
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2022
• 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
• Patient Outcome(s): Other