MAUDE Adverse Event Report: M AND C SCHIFFER GMBH DR. BEST HIGH LOW SOFT TOOTHBRUSH 1CT; TOOTHBRUSHES

Lot Number S4022776D

Device Problem Product Quality Problem (1506)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Loose brush pieces in throat [foreign body in throat], accidental swallowing of the toothbrush [accidental device ingestion], partially swallowed these bristles [foreign body ingestion], flush them out of my oral cavity [foreign body in mouth], case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body ingestion in a male patient who received gsk toothbrush (dr best (unknown variant)) 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 (unknown variant).On an unknown date, an unknown time after starting dr best (unknown variant), the patient experienced foreign body ingestion, foreign body in mouth and product complaint.The action taken with dr best (unknown variant) was unknown.On an unknown date, the outcome of the foreign body ingestion, foreign body in mouth and product complaint were unknown.It was unknown if the reporter considered the foreign body ingestion and foreign body in mouth to be related to dr best (unknown variant).Additional information: adverse event information was received via call center representative on 23 feb 2021.Consumer stated that while brushing the teeth the bristles simply got loose from the head.I have partially swallowed these and had to fight to manage to flush them out of my oral cavity with water.Follow up information was received on 25 feb 2021 from quality assurance (qa) department regarding complaint (b)(4) (issue number) for lot number unknown.The investigation reports concluded that, complaint stands unsubstantiated.Complaint sample not received at investigation site.This complaint has been investigated by our quality department and no conditions were discovered within gsk processes which would have caused or contributed to the reported event.The follow up information was received on 29 march 2021.The case was upgraded from non serious to serious, patient date of birth, suspect product details, action taken was updated and the additional events were added.The duration of application was 3min and the frequency was morning, at noon and evening.The patient stated that bristles come loose when brushing teeth.After using the product, the patient experienced loose brush pieces in mouth /throat /interdental spaces.The outcome of the events were resolved.Immediately the patient discontinued the product after use.The patient has not applied the product again.No additional medication and no primary diseases or risk factors were reported.The patient have not been to a doctor.Follow up information received from quality assurance department on 25 may 2021 for issue (b)(4) for batch s4022776dd.The suspect product was reported as dr.Best high low soft toothbrush 1ct.The toothbrush has very heavy traces of usage (deep scratches, deformed bristle field ,see pictures).After 6 years the production documents including all reports will be destroyed.Therefore, no production documents could be checked.The filaments are brittle and break if they were bended.The toothbrush looks like have been used for something else than for brushing teeth.No manufacturing error has been detected.The complaint stands unsubstantiated.

• Brand Name: DR. BEST HIGH LOW SOFT TOOTHBRUSH 1CT
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): M AND C SCHIFFER GMBH; neustadt, weid ; GM
• MDR Report Key: 11956976
• MDR Text Key: 267514852
• Report Number: 9615008-2021-00011
• 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
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: S4022776D
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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