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

Model Number 02106

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems Suffocation (2088); Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

Mfr report is associated with argus case (b)(4), dr.Best erste zaehne.Dr.Best erste zaehne is marketed as aquafresh infant training toothbrush in the us.

Event Description

Nearly suffocated due to a bristle [suffocation].She had one bristle (1 cm long) in the mouth [foreign body in mouth].Case description: this case was reported by a consumer via call center representative and described the occurrence of suffocation in a (b)(6) female patient who received gsk toothbrush (dr best erste zaehne) toothbrush for drug use for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started dr best erste zaehne at an unknown dose and frequency.On an unknown date, an unknown time after starting dr best erste zaehne, the patient experienced suffocation (serious criteria gsk medically significant), foreign body in mouth and product complaint.The action taken with dr best erste zaehne was unknown.On an unknown date, the outcome of the suffocation was not reported and the outcome of the foreign body in mouth and product complaint were unknown.It was unknown if the reporter considered the suffocation and foreign body in mouth to be related to dr best erste zaehne.Additional information: a mother reported that her daughter "nearly suffocated" due to a lost bristle of dr best erste zaehne.The infant bit on the brush and she had one bristle (1 cm long) in the mouth.The mother also explicitly reported, that her daughter did not chew on the product for minutes.Before the mother was able to remove the bristle out of the mouth of her daughter, she had already swallowed the bristle.The mother bought the same product again, in order to check if only the prior toothbrush had this quality deviation.The mother recognized that also the new toothbrush of dr best erste zaehne lost bristles easily.

Manufacturer Narrative

Dr.Best erste zaehne.Dr.Best erste zaehne is marketed as aquafresh infant training toothbrush in the us product complaint investigation report received on 08 february 2019: the review of manufacturing / packaging batch records is not possible due to the lack of batch number.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 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.No manufacturing error has been detected.

Event Description

This case was reported by a consumer via call center representative and described the occurrence of suffocation in a 14-month-old female patient who received gsk toothbrush (dr best erste zaehne) toothbrush for drug use for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started dr best erste zaehne at an unknown dose and frequency.On an unknown date, an unknown time after starting dr best erste zaehne, the patient experienced suffocation (serious criteria gsk medically significant), foreign body in mouth and product complaint.The action taken with dr best erste zaehne was unknown.On an unknown date, the outcome of the suffocation was not reported and the outcome of the foreign body in mouth and product complaint were unknown.It was unknown if the reporter considered the suffocation and foreign body in mouth to be related to dr best erste zaehne.Additional information: a mother reported that her daughter "nearly suffocated" due to a lost bristle of dr best erste zaehne.The infant bit on the brush and she had one bristle (1 cm long) in the mouth.The mother also explicitly reported, that her daughter did not chew on the product for minutes.Before the mother was able to remove the bristle out of the mouth of her daughter, she had already swallowed the bristle.The mother bought the same product again, in order to check if only the prior toothbrush had this quality deviation.The mother recognized that also the new toothbrush of dr best erste zaehne lost bristles easily.Follow up was received from quality assurance department on 08 feb 2019, quality assurance analysis revealed the complaint to be unsubstantiated.

• Brand Name: DR BEST ERSTE ZAEHNE
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): M AND C SCHIFFER GMBH; neustadt/weid, ; GM
• MDR Report Key: 8330972
• MDR Text Key: 135868805
• Report Number: 9615008-2019-00002
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 02106
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 MO