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

Device Problem Product Quality Problem (1506)

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

Event Type  Injury  

Event Description

White bristle came loose and became lodged in my throat [foreign body in throat], after minutes of choking [choking], struggling to breath [difficulty breathing], i had to vomit [vomiting].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 haleon toothbrush (dr best zwischenzahn) toothbrush (batch number unk, expiry date unknown) for dental cleaning.This case was associated with a product complaint.On an unknown date, the patient started dr best zwischenzahn.On an unknown date, an unknown time after starting dr best zwischenzahn, the patient experienced foreign body in throat (serious criteria haleon medically significant and other: serious per reporter), choking (serious criteria haleon medically significant and other: serious per reporter), difficulty breathing (serious criteria other: serious per reporter), vomiting (serious criteria other: serious per reporter) and product complaint.The action taken with dr best zwischenzahn was unknown.On an unknown date, the outcome of the foreign body in throat, choking, difficulty breathing and vomiting were recovered/resolved and the outcome of the product complaint was unknown.The reporter considered the foreign body in throat, choking, difficulty breathing and vomiting to be related to dr best zwischenzahn.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 (email) on (b)(6) 2023.The consumer reported that, "today, while brushing my teeth with your toothbrush, i had a serious incident.During brushing, a white bristle came loose and became lodged in my throat.After minutes of choking and struggling to breathe, i had to vomit, and it seems the bristle escaped from the throat area.As you can see in the pictures, this was a new toothbrush.How can something like this happen? is the toothbrush defective in such a case." follow up information was reported on 02oct2023.There was no new information reported to the case.Follow-up information was received on 06oct2023 from quality assurance (qa) department regarding product quality complaint with case number (b)(4) for unknown lot number.Investigation evaluation: complaint response haleon 30276 condition of complaint sample(s), description of complaint classification: critical receipt sample: schiffer didn't receive the sample for investigation, yet.Consumer verbatim, ladies and gentlemen i had a fatal incident with your toothbrush while brushing my teeth today.While brushing, a white bristle came loose and got stuck in the throat.After several minutes of wheezing and struggling to breathe, i had to throw up and the bristle must have escaped from the back of my throat.As you can see in the pictures it is a new toothbrush.How can something like that be? is the toothbrush defective in such an incident? notice: the following details assume that it is product of schiffer.Root cause analysis: the review of manufacturing / packaging batch records is not possible due to the lack of toothbrush/packaging batch number.Further investigation is not possible without receiving the batch number or 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.The investigation reports concluded that, complaint stands unsubstantiated.The pqc number was reported as (b)(4).The suspect drug was reported as dr.Best between teeth toothbrush unknown variant and size.

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: DR BEST ZWISCHENZAHN
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): M AND C SCHIFFER GMBH; neustadt/weid, ; GM
• Manufacturer Contact: 184 liberty corner road, suite 200; warren
• MDR Report Key: 18001074
• MDR Text Key: 326458917
• Report Number: 9615008-2023-00018
• 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: 10/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• 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: 10/01/2023
• 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