MAUDE Adverse Event Report: M AND C SCHIFFER GMBH DR. BEST HOCH-TIEF; TOOTHBRUSHES

Lot Number 32223

Device Problem Product Quality Problem (1506)

Patient Problem Choking (2464)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

I even choked when cleaning the back cheeks or wisdom teeth [choking].The protruding bristles hurt my gums [gum pain].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a 38-year-old patient who received gsk toothbrush (dr.(b)(6)) toothbrush (batch number 32223, expiry date unknown) for dental cleaning.This case was associated with a product complaint.On (b)(6) 2024, the patient started dr.(b)(6).On (b)(6) 2024, less than a day after starting dr.(b)(6), the patient experienced choking (serious criteria haleon medically significant) and gum pain.On an unknown date, the patient experienced product complaint.The action taken with dr.(b)(6) was unknown.On an unknown date, the outcome of the choking, gum pain and product complaint were unknown.The reporter considered the choking and gum pain to be related to dr.(b)(6).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 received from the consumer via call center representative (email) on (b)(6) 2024.Reporter stated that "i am years old and i am a convinced user of dr.(b)(6).Some weeks ago, i bought the toothbrush at a reliable pharmacy.After i unpacked it last night, i unfortunately saw that the front bristles were sticking out.I would have tried to brush my teeth today in the morning, but unfortunately it was impossible, since the protruding bristles hurt my gums, and i even choked when cleaning the back cheeks or wisdom teeth.How can this happen? this should be noticed during quality control!".

• Brand Name: DR. BEST HOCH-TIEF
• 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
• MDR Report Key: 18719274
• MDR Text Key: 335523775
• Report Number: 9615008-2024-00003
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 32223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2024
• 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: 38 YR