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

The baby was eating them, luckily nothing happened to him [accidental device ingestion].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a 11-month-old male patient who received haleon toothbrush (aquafresh baby teeth toothbrush) toothbrush (batch number unk, expiry date unknown) for dental cleaning.This case was associated with a product complaint.On an unknown date, the patient started aquafresh baby teeth toothbrush.On an unknown date, an unknown time after starting aquafresh baby teeth toothbrush, the patient experienced accidental device ingestion (serious criteria haleon medically significant) and product complaint.The action taken with aquafresh baby teeth toothbrush was unknown.On an unknown date, the outcome of the accidental device ingestion was recovered/resolved and the outcome of the product complaint was unknown.It was unknown if the reporter considered the accidental device ingestion to be related to aquafresh baby teeth toothbrush.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 from a consumer via call center representative (phone) on 14feb2024.The consumer reported that, "what i want is to inform you that i bought an aquafresh baby teeth from 0 to 2 years, a baby toothbrush from 0 to 2 years, baby teeth, for my 11-month-old son and it turns out that the bristles come out and the baby was eating them, luckily nothing happened to him, because i caught him in the shot, and i managed to take them out, i don't have the batch or expiration date, i threw away the container, the ticket, just i would like to notify".Follow up information was received on 14feb2024 from quality assurance(qa) department regarding complaint ((b)(4)) for lot number (unknown).Investigational evaluation: complaint verbatim: filaments (bristles) falling out during use filaments get loose during use filaments get stuck in my teeth / braces haleon code: cpc loose brist 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 brushhead, 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 investigational reports concluded that, complaint stands complaint inconclusive.The pqc number was reported as (b)(4).Initial and follow-up was processed together.

• Brand Name: AQUAFRESH BABY TEETH TOOTHBRUSH
• 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: 18757379
• MDR Text Key: 335991359
• Report Number: 9615008-2024-00004
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• 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: 02/14/2024
• 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: 11 MO
• Patient Sex: Male