MAUDE Adverse Event Report: M AND C SCHIFFER GMBH PARODONTAX COMPLETE PROTECTION; 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

I had to unpleasantly realize that during the brushing process the toothbrush loses its fine bristles which slip into the throat like fishbones.[foreign body in throat] this does not only feel uncomfortable [discomfort].Case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in throat in a female patient who received gsk toothbrush (parodontax complete protection) 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 parodontax complete protection.On an unknown date, an unknown time after starting parodontax complete protection, the patient experienced foreign body in throat (serious criteria gsk medically significant), discomfort and product complaint.The action taken with parodontax complete protection was unknown.On an unknown date, the outcome of the foreign body in throat, discomfort and product complaint were unknown.It was unknown if the reporter considered the foreign body in throat and discomfort to be related to parodontax complete protection.Initial and follow up was processed together.Additional details: adverse event information was received via call center representative (email) on 06 aug 2021.The consumer stated that "i recently bought one of your premium toothbrushes for almost (b)(6) on a (b)(6).Unfortunately, i had to unpleasantly realize that during the brushing process the toothbrush loses its fine bristles which slip into the throat like fishbones.This does not only feel uncomfortable but can be dangerous.I am deeply disappointed about this product and feel deceived because of the amount of money spent for such poor quality.Product complaint".Fu information: follow up information was received on 09 aug 2021 from qa department regarding complaint (b)(4)) for lot no.Unknown.Investigation evaluation:complaint sample is not available, toothbrush code is also not provided, so we are not able to check the retention sample production records of this batch.Only photographs of the complaint sample are shared through email.The investigation reports concluded that the complaint as inconclusive.

• Brand Name: PARODONTAX COMPLETE PROTECTION
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): M AND C SCHIFFER GMBH; neustadt, weid ; GM
• MDR Report Key: 12358555
• MDR Text Key: 267930642
• Report Number: 9615008-2021-00019
• 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: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• 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: 08/06/2021
• 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