MAUDE Adverse Event Report: M AND C SCHIFFER GMBH DR.BEST MILCHZAHN; TOOTHBRUSHES

Lot Number UNKNOWN

Device Problem Product Quality Problem (1506)

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

Event Date 11/14/2023

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

One of the green bristles had drilled into our client's right tonsil [tooth injury].One of the green bristles had drilled into our client's right tonsil [foreign body in throat].Case description: this case was reported by a (b)(6) via call center representative and described the occurrence of tooth injury in a 3-year-old male patient who received haleon toothbrush (dr.Best milchzahn) toothbrush (batch number unknown, expiry date unknown) for drug use for unknown indication.This case was associated with a product complaint.On (b)(6) 2023, the patient started dr.Best milchzahn.On (b)(6) 2023, an unknown time after starting dr.Best milchzahn, the patient experienced tooth injury (serious criteria clinically significant/intervention required) and foreign body in throat (serious criteria haleon medically significant and clinically significant/intervention required).On an unknown date, the patient experienced product complaint.The action taken with dr.Best milchzahn was unknown.On an unknown date, the outcome of the tooth injury and foreign body in throat were recovered/resolved and the outcome of the product complaint was unknown.It was unknown if the reporter considered the tooth injury and foreign body in throat to be related to dr.Best milchzahn.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 by consumer via call center representative (email) on 29dec2023.The consumer reported, "hello everyone, the following unwanted product complaint arrived in the post today: a 3-year-old boy injured himself so badly while brushing his teeth with a dr.Best milk teeth; that he had to have an operation.The family is demanding compensation of (b)(4) by (b)(6).Enclosed is the letter from the law firm commissioned by the parents.Three-year-old; was brushing his teeth with the dr.Best - milk teeth, rounded bristles; toothbrush on (b)(6) 2023, when he suddenly cried out.As it turned out, one of the green bristles had drilled into our client's right tonsil while he was brushing his teeth.Please see the attached photographs for the incident.Our client's mother, had previously purchased the toothbrush in the third quarter of 2023 at the dm drugstore;.On the day in question, took our client to the dental practice of dr;.After an examination, he determined that the remaining piece of the toothbrush had to be removed immediately.Then drove with our client to the hospital to the emergency room." follow up information was received on 31dec2023 from quality assurance (qa) department regarding product quality complaint with case number (b)(4) for unknown lot number.No sample was returned for this complaint and the lot/batch details were not received so a full investigation cannot be completed.As sufficient information is not available the complaint cannot be substantiated and will be closed as inconclusive.If the consumer contacts us with additional information, if the complaint sample is received or batch details are provided correctly, the complaint issue will be reopened and further evaluated.The investigation reports concluded that, complaint stands inconclusive.The pqc number was reported as (b)(4).Initial and fu information was processed together.

• Brand Name: DR.BEST MILCHZAHN
• 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: 18495130
• MDR Text Key: 332683722
• Report Number: 9615008-2024-00001
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2023
• 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): Required Intervention; Other
• Patient Age: 3 YR
• Patient Sex: Male