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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHUMEI INDUSTRIAL (HEBEI) CO LTD SENSODYNE DAILY CARE TOOTHBRUSH; TOOTHBRUSHES

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SHUMEI INDUSTRIAL (HEBEI) CO LTD SENSODYNE DAILY CARE TOOTHBRUSH; TOOTHBRUSHES Back to Search Results
Lot Number 180322340
Device Problem Product Quality Problem (1506)
Patient Problem Choking (2464)
Event Date 09/02/2022
Event Type  Injury  
Manufacturer Narrative
Argus case: (b)(4).
 
Event Description
He choked on it cause he was brushing toothbrush on his teeth.[choking] the whole clump of bristles all came out at once and went into his throat [foreign body in throat].He vomited like everywhere [vomiting].Just like this weiner at the back of his throat [throat discomfort].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a 7-year-old male patient who received gsk toothbrush (sensodyne daily care toothbrush) toothbrush (batch number 180322340, expiry date unknown) for dental cleaning.This case was associated with a product complaint.On (b)(6) 2022, the patient started sensodyne daily care toothbrush.On (b)(6) 2022, an unknown time after starting sensodyne daily care toothbrush, the patient experienced choking (serious criteria gsk medically significant and other: gsk medically significant), foreign body in throat (serious criteria gsk medically significant) and vomiting.On an unknown date, the patient experienced throat discomfort and product complaint.The action taken with sensodyne daily care toothbrush was unknown.On an unknown date, the outcome of the choking, foreign body in throat, vomiting, throat discomfort and product complaint were unknown.The reporter considered the choking to be related to sensodyne daily care toothbrush.It was unknown if the reporter considered the foreign body in throat, vomiting and throat discomfort to be related to sensodyne daily care toothbrush.This report is made by gsk/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 consumer via call center representative (phone) on (b)(6) 2022.Consumer reported that "hi i'm not sure, i just got the number for.I bought some sensodyne toothbrushes, like is there someone i can complain about them.Is there somebody i can talk about this or do i ring.It's like a 4 pack of daily care ones.I'm using the 4 but i've got them and my son was brushing his teeth on friday (b)(6) 2022 in the evening, and probably only have them 2 maybe 3 weeks and its whole bristle piece came out at once and went into his throat and he's only 7 and he choked on it and he vomited instantly which went on for about 2 minutes everywhere through the bathroom.Him and i were very scared and he was quite traumatized by the ordeal the toothbrush would have been purchased less than a month ago so it isn't due to being old.And yeah i just complained because i never had that happened with a toothbrush.I've had had the odd one bristle come out but this was a whole clump.Yeah, you know how the lined/little pieces.Yeah and the whole thing come out.Yeah he choked on it cause he's brushing toothbrush on his teeth.And it's just like this weiner at the back of his throat, choked on it, i mean.He's 7.And you know it quite catches on me and enough you know.Yeah i've got the toothbrush and i've got the packet it came with.Yeah i think, i think this 2 numbers.One is printed in black one is printed in blue.But one was stamped on and one is printed on it.The one starts with f and the this one just starts with a number.No it's f for frank.So it's f431tal7285.So there's another number that's just a number that looks like it printed on.Nine.180322340.Oh yeah so you can see like the name on it.I got it from pack and save in.And i think like it's nzd 10.Cause i like, they're like a really good size for children.Because it's quite hard to get that bigger brush with like a small hip.So do you want my email address.It's no that was all.I just really want to ring because if it's like a problem with like a bunch of them it was quite an awful experience." follow up information was received from qa department on 06sep2022 regarding complaint case number (b)(4) for lot number 180322340.The pqc number was reported as pqc158743.Initial and fu information was processed together.Follow up information was received on 14sep2022.It is reported that "we did not take him to a doctor it wasn't necessary , he was purely scared and traumatized from chocking but recovered at home".As per the follow up information the outcome of events "choking", "foreign body in throat"," vomiting", "throat discomfort" has been updated to "recovered/resolved".Follow up information was received on 20sep2022 from quality assurance (qa) department regarding complaint pqc158743 (issue number) for lot number 180322340.Investigation completion date: 2022-09-20 and investigation site shummi industrial hebei.Investigation evaluation: no defect sample available for further confirmation and investigation.After check on the defect picture, the toothbrush has been used for many times and abnormality is observed on the toothbrush head, the bristles are found seriously deformed and obvious dent mark is also found on one side of the toothbrush head.After referring to production and inspection records of this batch, no abnormality is found.After further review the complaint history of this batch product, no any complaint has been fed back.Based on the above analysis, it is preliminarily determined that the defect should be resulted from improper use of the consumer.Thus this complaint will be closed as unsubstantiated temporarily and the complaint will be re-opened when the defect sample is acquired.Based on the investigation, the investigation reports concluded that, complaint stands unsubstantiated.
 
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Brand Name
SENSODYNE DAILY CARE TOOTHBRUSH
Type of Device
TOOTHBRUSHES
Manufacturer (Section D)
SHUMEI INDUSTRIAL (HEBEI) CO LTD
zhou city,
CH 
Manufacturer Contact
184 liberty corner road
suite 200
warren, NJ 07059
8888255249
MDR Report Key15537629
MDR Text Key301155373
Report Number3006536571-2022-00001
Device Sequence Number1
Product Code EFW
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 09/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot Number180322340
Was Device Available for Evaluation? No
Date Manufacturer Received09/06/2022
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 Number1
Treatment
NO THERAPY (NO THERAPY)
Patient Outcome(s) Other;
Patient Age7 YR
Patient SexMale
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