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

Lot Number S3235397SB

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

Found brush bristle behind the tongue [foreign body in mouth].Case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in mouth in a 2-year-old female patient who received haleon toothbrush (dr best erste zaehne) toothbrush (batch number unk, expiry date unknown) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started dr best erste zaehne.On an unknown date, an unknown time after starting dr best erste zaehne, the patient experienced foreign body in mouth (serious criteria other: per reporter) and product complaint.Dr best erste zaehne was discontinued (dechallenge was unknown).On an unknown date, the outcome of the foreign body in mouth and product complaint were unknown.The reporter considered the foreign body in mouth to be related to dr best erste zaehne.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 23jan2024.The consumer reported,"we'd like to warn about a defect of this toothbrush for kinder.Our daughter started suddenly to gulp and cry after brushing her teeth, until we found brush bristle behind the tongue and fortunately we could take them out.We've only used the brush for 7 days.We are really horrified, for such a serious lack of quality of dr.Best.Until know, we didn't know this from this company".Follow up 1 was received on 23jan2024 and image of the product was received.Follow up 2 information was received on 23jan2024 from quality assurance (qa) department regarding product quality complaint with case number: (b)(4) for unknown lot number.Investigation evaluation:check if the duration of use of the brush is known or approximately known.Check if brush is (heavily) used.Overall appearance (spread filaments, scratches on the backside of the brush head, toothpaste residue between tufts of bristles and in grooves of handle) as well as smell of toothpaste flavor are indicators.Sometimes, squeeze or bite marks can be seen on the filaments.Response to consumer: this complaint has been investigated by our quality department and no conditions were discovered within our processes which would have caused or contributed to the reported event.Applying too much pressure during brushing or too long usage of brush may cause this type of defect the investigation reports concluded that, complaint stands inconclusive.The pqc number was reported as (b)(4).Initial and follow up 1 and 2 processed together.

Manufacturer Narrative

Argus case:(b)(4).

Event Description

Found brush bristle behind the tongue [foreign body in mouth].Our daughter suddenly started choking [choking sensation].Case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in mouth in a 2-year-old female patient who received haleon toothbrush (dr best erste zaehne) toothbrush (batch number unk, expiry date unknown) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started dr best erste zaehne.On an unknown date, an unknown time after starting dr best erste zaehne, the patient experienced foreign body in mouth (serious criteria other: per reporter) and product complaint.Dr best erste zaehne was discontinued (dechallenge was unknown).On an unknown date, the outcome of the foreign body in mouth and product complaint were unknown.The reporter considered the foreign body in mouth to be related to dr best erste zaehne.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 23jan2024.The consumer reported,"we'd like to warn about a defect of this toothbrush for kinder.Our daughter started suddenly to gulp and cry after brushing her teeth, until we found brush bristle behind the tongue and fortunately we could take them out.We've only used the brush for 7 days.We are really horrified, for such a serious lack of quality of dr.Best.Until now, we didn't know this from this company".Follow up 1 was received on 23jan2024 and image of the product was received.Follow up 2 information was received on 23jan2024 from quality assurance (qa) department regarding product quality complaint with case number (b)(4) for unknown lot number.Investigation evaluation:check if the duration of use of the brush is known or approximately known.Check if brush is (heavily) used.Overall appearance (spread filaments, scratches on the backside of the brush head, toothpaste residue between tufts of bristles and in grooves of handle) as well as smell of toothpaste flavor are indicators.Sometimes, squeeze or bite marks can be seen on the filaments.Response to consumer: this complaint has been investigated by our quality department and no conditions were discovered within our processes which would have caused or contributed to the reported event.Applying too much pressure during brushing or too long usage of brush may cause this type of defect.The investigation reports concluded that, complaint stands inconclusive.The pqc number was reported as (b)(4).Initial and follow up 1 and 2 processed together.Follow up information was received on 26jan2024 from quality assurance (qa) department regarding product quality complaint with case number (b)(4) for lot number s3235397sb.Investigation evaluation: 2024-01-26 08:02:59: complaint repsonse # haleon 40024 condition of complaint sample(s), description of complaint classification : critical reciept sample: schiffer received one sample for investigation.Notice : the following details assume that it is product of schiffer.Root cause analysis 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.Photo documentation; the investigation reports concluded that, complaint stands unsubstantiated.The pqc number was reported as (b)(4).Follow up 3 and 4 were processed together.Follow up 5 information was received on 01feb2024 from quality assurance (qa) department regarding product quality complaint with case number (b)(4) for lot number s3235397sb.It stated as our daughter suddenly started choking and crying.Follow up 6 information was received on 31jan2024 from quality assurance (qa) department regarding product quality complaint with case number (b)(4) for lot number s3235397sb.It was stated as this number is not visible on photos/videos.The product was purchased in a store on january 15, 2024 around 11 am.For the scare to our daughter, the time spent reporting this to you so that these products are checked, getting a new children's toothbrush and convincing the toddler to continue brushing her teeth without having a fishbone-like brush hair stuck in her neck does not justify just getting a refund for the product.You should check this aspect of an apology again.

• Brand Name: DR BEST ERSTE ZAEHNE
• 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: 18612019
• MDR Text Key: 334141117
• Report Number: 9615008-2024-00002
• 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,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: S3235397SB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2024
• 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: 24 MO
• Patient Sex: Female