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

Device Problem Product Quality Problem (1506)

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

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

A new toothbrush came loose and stuck in my husband's neck/ choking [choking].Stuck in my husband's neck [foreign body in throat].Cough [cough].Vomiting [vomiting].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a adult male patient who received haleon toothbrush (dr (b)(6) (unknown variant)) toothbrush (batch number s3102061s, expiry date unknown) for product used for unknown indication.The patient's past medical history included hospitalization.On an unknown date, the patient started dr (b)(6) (unknown variant) at an unknown dose and frequency.On an unknown date, an unknown time after starting dr (b)(6)(unknown variant), the patient experienced choking (serious criteria haleon medically significant), foreign body in throat (serious criteria haleon medically significant), cough and vomiting.Dr (b)(6) (unknown variant) was discontinued (dechallenge was positive).On an unknown date, the outcome of the choking, cough and vomiting were recovered/resolved and the outcome of the foreign body in throat was unknown.It was unknown if the reporter considered the choking, cough and vomiting to be related to dr (b)(6) (unknown variant).The reporter considered the foreign body in throat to be related to dr (b)(6) (unknown variant).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 consumer via call center representative on (b)(6) 2023.It was reported that "years ago the problem that the bristles of a new toothbrush came loose and stuck in my husband's neck.At that time with treatment in the hospital.Now this has happened again.Symptoms: cough, vomiting, choking.Problem was reported as : the bristles of the toothbrush came loose.Outcome was reported as recovered.Has the patient stop using the product? was answered as "yes".And not used it again.Gender was reported as male.Lot number was reported as s3102061s." the suspect product was reported as dr.(b)(6) [toothbrush].Follow up information was received on 27oct2023 from quality assurance (qa) department regarding complaint (b)(4) for unknown lot number.Additional details: nt incorrect/invalid batch s3102061s, hence why expiry date cannot be verified.However, this is a critical case and a single site product, so case will be triaged investigation evaluation: (b)(6) 2023 complaint response (b)(4).Condition of complaint sample(s), description of complaint.Classification : expedite complaint.Receipt sample: didn't receive the sample for investigation, yet.Consumer verbatim in english: "good day, years ago we had the problem that the bristles of a new toothbrush came loose and stuck in my husband's throat.At that time he was being treated in hospital.Now this has happened again.How can it be that a new toothbrush shows such a defect? " notice : the following details assume that it is product of schiffer.Root cause analysis: the review of manufacturing or packaging batch records did not indicate that this complaint may be due to a processing problem.A trend analysis with same product of complaint subject shows no abnormalities.No recall has been started by this article.Further investigation is not possible without receiving the complaint sample.This complaint has been logged and will be evaluated and present in the monthly complaint review process.On the basis of the above the complaint is considered as closed.With the receipt of the complaint sample, the complaint will be re opened and further investigation carried out as required.A final report will be issued in accordance with the quality agreement within 30 days after receiving the complaint sample.Complaint conclusion: the complaint was concluded as unsubstantiated.The pqc number was reported as (b)(4).The suspect product was updated from dr (b)(6) (unknown variant) to dr (b)(6) polimed with batch lot number as unknown.

• Brand Name: DR. BEST POLIMED
• 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: 18117762
• MDR Text Key: 327867977
• Report Number: 9615008-2023-00019
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• 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: 10/27/2023
• 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 Sex: Male