MAUDE Adverse Event Report: M AND C SCHIFFER GMBH AQUAFRESH LITTLE 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 id: (b)(4).

Event Description

There is little bits that are connected to the surface but there is another particle that i imagine my son has swallowed [accidental device ingestion by a child].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion by a child in a (b)(6)-year-old male patient who received gsk toothbrush ((b)(6) little 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 (b)(6) little teeth toothbrush.On an unknown date, an unknown time after starting (b)(6) little teeth toothbrush, the patient experienced accidental device ingestion by a child (serious criteria gsk medically significant) and product complaint.The action taken with (b)(6) little teeth toothbrush was unknown.On an unknown date, the outcome of the accidental device ingestion by a child and product complaint were unknown.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Adverse event information was received on 26-may-2021 via call center representative (phone), the consumer stated that "the upper part you get the plastic out and the little plastic piece that goes to my son's mouth, he can swallow it.A model comes out and i don't see it furthermore with children, with every person, but more with children.Like stripped at the end, on the back part of the brush.At the end like the plastic, like the plastic film that comes out and there is little bits that are connected to the surface but there is another particle that i imagine my son has swallowed.It was not like out of the box.I do not have a lot number.Yes, like little bits.I mean, he's still alive obviously.Reporter does not wish to provide patient or hsi information." name of product quality complaint: (b)(4).

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion by a child in a 5-year-old male patient who received gsk toothbrush (aquafresh little 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 little teeth toothbrush.On an unknown date, an unknown time after starting aquafresh little teeth toothbrush, the patient experienced accidental device ingestion by a child (serious criteria gsk medically significant) and product complaint.The action taken with aquafresh little teeth toothbrush was unknown.On an unknown date, the outcome of the accidental device ingestion by a child and product complaint were unknown.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Adverse event information was received on 26-may-2021 via call center representative (phone), the consumer stated that "the upper part you get the plastic out and the little plastic piece that goes to my son's mouth, he can swallow it.A model comes out and i don't see it furthermore with children, with every person, but more with children.Like stripped at the end, on the back part of the brush.At the end like the plastic, like the plastic film that comes out and there is little bits that are connected to the surface but there is another particle that i imagine my son has swallowed.It was not like out of the box.I do not have a lot number.Yes, like little bits.I mean, he's still alive obviously.Reporter does not wish to provide patient or hsi information." name of product quality complaint: (b)(4).Follow-up information was received on 13aug2022 from quality assurance (qa) department regarding product quality complaint with case number: (b)(4) for lot number unknown.Investigation evaluation: complaint sample is not available, photographs of the complaint sample are not provided and toothbrush code is also not provided, so we are not able to check the retention sample and production records of this batch.The investigation reports concluded that, complaint stands inconclusive.The pqc number was reported as (b)(4).Additional details: the consumer mentions that she no longer has the box so she cannot provide the batch or expiration date.Case correction performed on initially processed document received on 26may2021.The causality of the event accidental device ingestion by a child was updated from not applicable to unknown.

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: AQUAFRESH LITTLE 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 ; 8888255249
• MDR Report Key: 11965835
• MDR Text Key: 255096005
• Report Number: 9615008-2021-00012
• 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,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2022
• 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: 5 YR
• Patient Sex: Male