MAUDE Adverse Event Report: M AND C SCHIFFER GMBH SENSODYNE SENSITIVITY AND GUM SOFT TOOTHBRUSH; TOOTHBRUSHES

Lot Number 1100236

Device Problem Product Quality Problem (1506)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/18/2022

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

I felt foreign bodies in my throat [foreign body in throat].That caused me severe spasms [spasms].A strong sense of vomiting, vomit stimuli [nausea].Case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in throat in a patient who received gsk toothbrush (sensodyne sensitivity and gum soft toothbrush) toothbrush (batch number: m44005900, expiry date unknown) for oral hygiene.This case was associated with a product complaint.On (b)(6) 2022, the patient started sensodyne sensitivity and gum soft toothbrush.On (b)(6) 2022, less than a minute after starting sensodyne sensitivity and gum soft toothbrush, the patient experienced foreign body in throat (serious criteria gsk medically significant), spasms and nausea.On an unknown date, the patient experienced product complaint.The action taken with sensodyne sensitivity and gum soft toothbrush was unknown.On an unknown date, the outcome of the foreign body in throat, spasms, nausea and product complaint were unknown.It was unknown if the reporter considered the foreign body in throat, spasms and nausea to be related to sensodyne sensitivity and gum soft 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 received from a consumer via call center representative (email) on 18nov2022.The consumer reported that, "i am and i am a resident of campania.I write to report something that happened to me with your product, which i think is very serious.On (b)(6) 2022, i purchased a sensodyne new design soft toothbrush at.Today, on (b)(6) 2022, i opened the packaging and used the brush in question for the first time.Well, after a few seconds of use in performing the mouth rinse operations, i felt foreign bodies in my throat that caused me severe spasms and a strong sense of vomiting.After coming out of the unpleasant situation, i found that the vomit stimuli was caused by the brush bristles that detached as they were not fixed as they should be.In this regard, i was able to find that almost most of the bristles were not fixed well, as a photo i attach (brush with bristles that slip off, purchase receipt, brush outer box).I am confident in your feedback and any control over the batch in question".Follow up information was received on 21nov2022 from consumer relation hub and reported" gender.Age 41.End date of product intake/use: the day of reporting.Did the adverse event resolve.Have your symptoms gone away.It resolved but i had burning in my throat for more than one day.End date of adverse event.Did you have to take any medications no.The sample is available, so haleon is activated to send a courier to take it for further investigations.(if you agree, please tell us your address) the sample is available.My address and".The patient age added as 41.Follow up information was received on 24nov2022 from quality assurance (qa) department regarding product quality complaint with case number (b)(4) for lot number: 1100236.Batch lot was updated to 1100236 from m44005900.Investigation evaluation:complaint sample is not available, only photographs of the complaint sample is shared through email.Toothbrush code is also not provided, so we are not able to check the retention sample and production records of this batch.Photographs shows one tuft hole without bristles, which came out of the tuft hole along with anchor wire while brushing the teeth.Anchor wire impression can be seen on the tuft hole, which shows that the bristles were tufted with anchor wire.The bristles and anchor wire might have pulled out due to excessive force used by consumer while brushing".The investigation reports concluded that, complaint stands complaint inconclusive.The pqc number was reported as (b)(4).Follow up information was received on 06dec2022 from quality assurance department regarding complaint issue number: (b)(4) for 1100236 lot number.As per the fu qa information no new information was added.

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

I felt foreign bodies in my throat [foreign body in throat] that caused me severe spasms [spasms] a strong sense of vomiting, vomit stimuli [nausea] vomiting [vomiting] case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in throat in a patient who received gsk toothbrush (sensodyne sensitivity and gum soft toothbrush) toothbrush (batch number m44005900, expiry date unknown) for oral hygiene.This case was associated with a product complaint.On (b)(6) 2022, the patient started sensodyne sensitivity and gum soft toothbrush.On (b)(6) 2022, less than a minute after starting sensodyne sensitivity and gum soft toothbrush, the patient experienced foreign body in throat (serious criteria gsk medically significant), spasms and nausea.On an unknown date, the patient experienced product complaint.The action taken with sensodyne sensitivity and gum soft toothbrush was unknown.On an unknown date, the outcome of the foreign body in throat, spasms, nausea and product complaint were unknown.It was unknown if the reporter considered the foreign body in throat, spasms and nausea to be related to sensodyne sensitivity and gum soft 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 received from a consumer via call center representative (email) on (b)(6) 2022.The consumer reported that, "i am and i am a resident of campania.I write to report something that happened to me with your product, which i think is very serious.On (b)(6) 2022, i purchased a sensodyne new design soft toothbrush at.Today, (b)(6) 2022, i opened the packaging and used the brush in question for the first time.Well, after a few seconds of use in performing the mouth rinse operations, i felt foreign bodies in my throat that caused me severe spasms and a strong sense of vomiting.After coming out of the unpleasant situation, i found that the vomit stimuli was caused by the brush bristles that detached as they were not fixed as they should be.In this regard, i was able to find that almost most of the bristles were not fixed well, as a photo i attach (brush with bristles that slip off, purchase receipt, brush outer box).I am confident in your feedback and any control over the batch in question".Follow up information was received on 21nov2022 from consumer relation hub and reported" gender.Age 41.End date of product intake/use: the day of reporting.Did the adverse event resolve.Have your symptoms gone away.It resolved but i had burning in my throat for more than one day.End date of adverse event.Did you have to take any medications no.The sample is available, so haleon is activated to send a courier to take it for further investigations.(if you agree, please tell us your address) the sample is available.My address and".The patient age added as 41.Follow up information was received on 24nov2022 from quality assurance (qa) department regarding product quality complaint with case number (b)(4) for lot number 1100236.Batch lot was updated to 1100236 from m44005900.Investigation evaluation:complaint sample is not available, only photographs of the complaint sample is shared through email.Toothbrush code is also not provided, so we are not able to check the retention sample and production records of this batch.Photographs shows one tuft hole without bristles, which came out of the tuft hole along with anchor wire while brushing the teeth.Anchor wire impression can be seen on the tuft hole, which shows that the bristles were tufted with anchor wire.The bristles and anchor wire might have pulled out due to excessive force used by consumer while brushing".The investigation reports concluded that, complaint stands complaint inconclusive.The pqc number was reported as (b)(4).Follow up information was received on 06dec2022 from quality assurance department regarding complaint issue number:(b)(4) for 1100236 lot number.As per the fu qa information no new information was added.Follow up information was received on 27dec2022.The consumer reported that 'i wanted to report that i did not contact the treating physician for the adverse event in question because the vomiting resolved on its own after some spasms.' the event vomiting is added with unknown causality and event outcome as recovered/resolved.

• Brand Name: SENSODYNE SENSITIVITY AND GUM SOFT 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: 15985559
• MDR Text Key: 305497593
• Report Number: 9615008-2022-00011
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 1100236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2022
• 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: 41 YR