MAUDE Adverse Event Report: M AND C SCHIFFER GMBH AQUAFRESH BIG TEETH TOOTHBRUSH; TOOTHBRUSHES

Device Problem Product Quality Problem (1506)

Patient Problem Choking (2464)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

It snapped and choked him [choking].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a (b)(6) year-old male patient who received gsk toothbrush (aquafresh big teeth toothbrush) 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 aquafresh big teeth toothbrush.On an unknown date, an unknown time after starting aquafresh big teeth toothbrush, the patient experienced choking (serious criteria gsk medically significant) and product complaint.The action taken with aquafresh big teeth toothbrush was unknown.On an unknown date, the outcome of the choking and product complaint were unknown.It was unknown if the reporter considered the choking to be related to aquafresh big teeth toothbrush.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: adverse event information received via call center representative on 05-jun-2021.The consumer stated that, "i purchased a childs toothbrush for my (b)(6) year old son, upon using it after several times it snapped and choked him! if it had snapped completely i dread to think of the outcome.I am so angry about this and it has caused me so much anxiety.Please see attached photos.This needs to be reviewed." follow up information received on 08 jun 2021 from quality assurance (qa) department regarding pqc number: (b)(4) for lot number unknown.The investigation reports were inconclusive.Investigation evaluation: no sample was returned for this complaint and the lot/batch details were not received so a full investigation cannot be completed.As sufficient information is not available the complaint cannot be substantiated and will be closed as inconclusive.If the consumer contacts us with additional information, if the complaint sample is received or batch details are provided correctly, the complaint issue will be reopened and further evaluated.Follow ups (fu1, fu 2, fu3 and fu4) received on 07-jun-2021 are same and copied with pqc number and conclusion and evaluation as on 08 jun 2021.This case is created for child and is linked to reporter's case id: (b)(4).

• Brand Name: AQUAFRESH BIG TEETH TOOTHBRUSH
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): M AND C SCHIFFER GMBH; neustadt/weid ; GM
• MDR Report Key: 12021018
• MDR Text Key: 267903804
• Report Number: 9615008-2021-00015
• 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: 06/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• 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: 06/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 9 YR