| Lot Number M8086H |
| Device Problem
Product Quality Problem (1506)
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| Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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Foreign body in throat and oropharyngeal discomfort [pharynx strange sensation of].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 (shumitect toothbrush (unknown)) toothbrush for oral hygiene.On an unknown date, the patient started shumitect toothbrush (unknown).On an unknown date, an unknown time after starting shumitect toothbrush (unknown), the patient experienced foreign body in throat (serious criteria gsk medically significant), pharynx strange sensation of and product quality issue.On an unknown date, the outcome of the foreign body in throat, pharynx strange sensation of and product quality issue were unknown.It was unknown if the reporter considered the foreign body in throat and pharynx strange sensation of to be related to shumitect toothbrush (unknown).This report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.[clinical course] on an unknown date, a brush fell out and adhered to the back of the throat (seriousness: gsk medically significant).The patient had a strange feeling (seriousness: non-serious).While the patient was brushing teeth, the brush fell out and adhered to the back of the throat.He/she removed some with fingers, but he/she still had a strange feeling.Although it flowed with water on rinsing, he/she only took a picture of what he/she took out of the mouth.No further information is expected.Follow-up information received on 31 august 2023 additional details: on 28-aug-2023, the product related to product complaint which was returned from the customer was received.[summary of investigation] case number: (b)(4).Related interaction: (b)(4).Gsk receipt date: 23/08/2023.Complaint country: japan.Product name: pqc210712.Global product description: sensodyne shumitect toothbrush unknown variant and size.Primary package lot number: unk.Criticality: critical.Related hsi / ae: hsi-179778.Hsi related case number: (b)(4).Investigation evaluation: 2023-08-31 08:51:05: no defect sample or valid date code available for further confirmation and investigation.According to the defect picture, it is preliminarily determined that there were 2 anchor wires in the defective hole, causing the brush filament to be cut off by the anchor wire and the filaments to fall off during use.Further analyzed with the workshop technician, the possible reasons are as follows: in the tufting process, the toothbrush handle may occasionally drop.The tufting machine continues to work without toothbrush handle, resulting in residual bristles on the tufting needle or the anchor wire is not sent out.After the operator found that the tufting was abnormal, the tufting machine was reset and the resumed the production directly, resulting in two anchor wires in the first hole of the next toothbrush handle.The workshop has revised the tufting, trimming and end-rounding machine sop, it is required that if any handle falling off or no handle on the tufting machine found, the tufting operator should stop the machine immediately, after manually operating the tufting machine to make all the remaining filaments or anchor wire in the nozzle be push out, then reset the machine and resume production.At the same time, the operator should check and confirm the first tufted toothbrush after resuming production.In addition, the workshop has installed handle auto-loading device in the tufting stage in july 2023, to avoid the situation of the 2 anchor wires in one hole and filament dropped caused by the toothbrush handle dropped.This complaint will be closed as a confirmation complaint and the complaint will be re-opened when the defect sample is acquired.Response to consumer (if applicable): complaint conclusion: substantiated.Investigation completion date: 2023-08-31 08:51:06.
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Manufacturer Narrative
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Argus case: (b)(4).
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Manufacturer Narrative
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Argus case: (b)(4).
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Event Description
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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 (shumitect toothbrush (unknown)) toothbrush for oral hygiene.On an unknown date, the patient started shumitect toothbrush (unknown).On an unknown date, an unknown time after starting shumitect toothbrush (unknown), the patient experienced foreign body in throat (serious criteria gsk medically significant), pharynx strange sensation of and product quality issue.On an unknown date, the outcome of the foreign body in throat, pharynx strange sensation of and product quality issue were unknown.It was unknown if the reporter considered the foreign body in throat and pharynx strange sensation of to be related to shumitect toothbrush (unknown).This report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.[clinical course] on an unknown date, a brush fell out and adhered to the back of the throat (seriousness: gsk medically significant).The patient had a strange feeling (seriousness: non-serious).While the patient was brushing teeth, the brush fell out and adhered to the back of the throat.He/she removed some with fingers, but he/she still had a strange feeling.Although it flowed with water on rinsing, he/she only took a picture of what he/she took out of the mouth.No further information is expected.Follow-up information received on 31 august 2023 additional details: on 28-aug-2023, the product related to product complaint which was returned from the customer was received.[summary of investigation] case number: (b)(4).Related interaction: (b)(4) gsk receipt date: 23/08/2023.Complaint country: (b)(4).Product name: pqc210712.Global product description: sensodyne shumitect toothbrush unknown variant and size.Primary package lot number: unk.Criticality: critical.Investigation results: related hsi / ae: hsi-179778.Hsi related case number: (b)(4) investigation evaluation: 2023-08-31 08:51:05: no defect sample or valid date code available for further confirmation and investigation.According the defect picture, it is preliminarily determined that there were 2 anchor wires in the defective hole, causing the brush filament to be cut off by the anchor wire and the filaments to fall off during use.Further analyzed with the workshop technician, the possible reasons are as follows: in the tufting process, the toothbrush handle may occasionally drop.The tufting machine continues to work without toothbrush handle, resulting in residual bristles on the tufting needle or the anchor wire is not sent out.After the operator found that the tufting was abnormal, the tufting machine was reset and the resumed the production directly, resulting in two anchor wires in the first hole of the next toothbrush handle.The workshop has revised the tufting, trimming and end-rounding machine sop, it is required that if any handle falling off or no handle on the tufting machine found, the tufting operator should stop the machine immediately, after manually operating the tufting machine to make all the remaining filaments or anchor wire in the nozzle be push out, then reset the machine and resume production.At the same time, the operator should check and confirm the first tufted toothbrush after resuming production.In addition, the workshop has installed handle auto-loading device in the tufting stage in july 2023, to avoid the situation of the 2 anchor wires in one hole and filament dropped caused by the toothbrush handle dropped.This complaint will be closed as a confirmation complaint and the complaint will be re-opened when the defect sample is acquired.; response to consumer (if applicable): complaint conclusion: substantiated.Investigation completion date: 2023-08-31 08:51:06.Follow-up information received on 7 september 2023.Additional details: [summary of investigation].Case number: (b)(4).Related interaction: (b)(4).Gsk receipt date: 23/08/2023.Complaint country: (b)(4).Product name: pqc210712.Global product description: sensodyne shumitect toothbrush unknown variant and size.Primary package lot number: m8086h.Criticality: critical.Investigation results: related hsi / ae: hsi-179778.Hsi related case number: (b)(4).Investigation evaluation: 2023-08-31 08:51:05: no defect sample or valid date code available for further confirmation and investigation.According the defect picture, it is preliminarily determined that there were 2 anchor wires in the defective hole, causing the brush filament to be cut off by the anchor wire and the filaments to fall off during use.Further analyzed with the workshop technician, the possible reasons are as follows: in the tufting process, the toothbrush handle may occasionally drop.The tufting machine continues to work without toothbrush handle, resulting in residual bristles on the tufting needle or the anchor wire is not sent out.After the operator found that the tufting was abnormal, the tufting machine was reset and the resumed the production directly, resulting in two anchor wires in the first hole of the next toothbrush handle.The workshop has revised the tufting, trimming and end-rounding machine sop, it is required that if any handle falling off or no handle on the tufting machine found, the tufting operator should stop the machine immediately, after manually operating the tufting machine to make all the remaining filaments or anchor wire in the nozzle be push out, then reset the machine and resume production.At the same time, the operator should check and confirm the first tufted toothbrush after resuming production.In addition, the workshop has installed handle auto-loading device in the tufting stage in july 2023, to avoid the situation of the 2 anchor wires in one hole and filament dropped caused by the toothbrush handle dropped.T his complaint will be closed as a confirmation complaint and the complaint will be re-opened when the defect sample is acquired.; response to consumer (if applicable): complaint conclusion: substantiated.Investigation completion date: 2023-09-07 23:36:30.
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Event Description
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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 (shumitect toothbrush (unknown)) toothbrush for oral hygiene.On an unknown date, the patient started shumitect toothbrush (unknown).On an unknown date, an unknown time after starting shumitect toothbrush (unknown), the patient experienced foreign body in throat (serious criteria gsk medically significant), pharynx strange sensation of and product quality issue.On an unknown date, the outcome of the foreign body in throat, pharynx strange sensation of and product quality issue were unknown.It was unknown if the reporter considered the foreign body in throat and pharynx strange sensation of to be related to shumitect toothbrush (unknown).This report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.[clinical course].On an unknown date, a brush fell out and adhered to the back of the throat (seriousness: gsk medically significant).The patient had a strange feeling (seriousness: non-serious).While the patient was brushing teeth, the brush fell out and adhered to the back of the throat.He/she removed some with fingers, but he/she still had a strange feeling.Although it flowed with water on rinsing, he/she only took a picture of what he/she took out of the mouth.No further information is expected.Follow-up information received on 31 august 2023.Additional details: on 28-aug-2023, the product related to product complaint which was returned from the customer was received.[summary of investigation] case number: (b)(4).Related interaction: 05233561.Gsk receipt date: 23/08/2023.Complaint country: japan.Product name: pqc210712.Global product description: sensodyne shumitect toothbrush unknown variant and size.Primary package lot number: unk.Criticality: critical.Investigation results: related hsi / ae: hsi-179778 hsi related case number: (b)(4).Investigation evaluation: 2023-08-31 08:51:05: no defect sample or valid date code available for further confirmation and investigation.According the defect picture, it is preliminarily determined that there were 2 anchor wires in the defective hole, causing the brush filament to be cut off by the anchor wire and the filaments to fall off during use.Further analyzed with the workshop technician, the possible reasons are as follows: in the tufting process, the toothbrush handle may occasionally drop.The tufting machine continues to work without toothbrush handle, resulting in residual bristles on the tufting needle or the anchor wire is not sent out.After the operator found that the tufting was abnormal, the tufting machine was reset and the resumed the production directly, resulting in two anchor wires in the first hole of the next toothbrush handle.The workshop has revised the tufting, trimming and end-rounding machine sop, it is required that if any handle falling off or no handle on the tufting machine found, the tufting operator should stop the machine immediately, after manually operating the tufting machine to make all the remaining filaments or anchor wire in the nozzle be push out, then reset the machine and resume production.At the same time, the operator should check and confirm the first tufted toothbrush after resuming production.In addition, the workshop has installed handle auto-loading device in the tufting stage in july 2023, to avoid the situation of the 2 anchor wires in one hole and filament dropped caused by the toothbrush handle dropped.This complaint will be closed as a confirmation complaint and the complaint will be re-opened when the defect sample is acquired.; response to consumer (if applicable): complaint conclusion: substantiated investigation completion date: 2023-08-31 08:51:06.Follow-up information received on 7 september 2023.Additional details: [summary of investigation] case number: (b)(4).Related interaction: 05233561.Gsk receipt date: 23/08/2023.Complaint country: japan.Product name: pqc210712.Global product description: sensodyne shumitect toothbrush unknown variant and size.Primary package lot number: m8086h.Criticality: critical investigation results: related hsi / ae: hsi-179778 hsi related case number: (b)(4).Investigation evaluation: 2023-08-31 08:51:05: no defect sample or valid date code available for further confirmation and investigation.According the defect picture, it is preliminarily determined that there were 2 anchor wires in the defective hole, causing the brush filament to be cut off by the anchor wire and the filaments to fall off during use.Further analyzed with the workshop technician, the possible reasons are as follows: in the tufting process, the toothbrush handle may occasionally drop.The tufting machine continues to work without toothbrush handle, resulting in residual bristles on the tufting needle or the anchor wire is not sent out.After the operator found that the tufting was abnormal, the tufting machine was reset and the resumed the production directly, resulting in two anchor wires in the first hole of the next toothbrush handle.The workshop has revised the tufting, trimming and end-rounding machine sop, it is required that if any handle falling off or no handle on the tufting machine found, the tufting operator should stop the machine immediately, after manually operating the tufting machine to make all the remaining filaments or anchor wire in the nozzle be push out, then reset the machine and resume production.At the same time, the operator should check and confirm the first tufted toothbrush after resuming production.In addition, the workshop has installed handle auto-loading device in the tufting stage in july 2023, to avoid the situation of the 2 anchor wires in one hole and filament dropped caused by the toothbrush handle dropped.T his complaint will be closed as a confirmation complaint and the complaint will be re-opened when the defect sample is acquired.; response to consumer (if applicable): complaint conclusion: substantiated investigation completion date: 2023-09-07 23:36:30.Follow-up information received on 22 september 2023 a special situation "expired product administered" was added from this report.Additional details: [summary of investigation] case number: (b)(4).Related interaction: 05233561.Gsk receipt date: 23/08/2023.Complaint country: japan.Product name: pqc210712.Global product description: sensodyne 3 dimensional medium toothbrush 1ct.Primary package lot number: m8086h.Criticality: critical.Investigation results: related hsi / ae: hsi-179778.Hsi related case number: (b)(4).Investigation evaluation: 2023-08-31 08:51:05: no defect sample or valid date code available for further confirmation and investigation.According the defect picture, it is preliminarily determined that there were 2 anchor wires in the defective hole, causing the brush filament to be cut off by the anchor wire and the filaments to fall off during use.Further analyzed with the workshop technician, the possible reasons are as follows: in the tufting process, the toothbrush handle may occasionally drop.The tufting machine continues to work without toothbrush handle, resulting in residual bristles on the tufting needle or the anchor wire is not sent out.After the operator found that the tufting was abnormal, the tufting machine was reset and the resumed the production directly, resulting in two anchor wires in the first hole of the next toothbrush handle.The workshop has revised the tufting, trimming and end-rounding machine sop, it is required that if any handle falling off or no handle on the tufting machine found, the tufting operator should stop the machine immediately, after manually operating the tufting machine to make all the remaining filaments or anchor wire in the nozzle be push out, then reset the machine and resume production.At the same time, the operator should check and confirm the first tufted toothbrush after resuming production.In addition, the workshop has installed handle auto-loading device in the tufting stage in july 2023, to avoid the situation of the 2 anchor wires in one hole and filament dropped caused by the toothbrush handle dropped.This complaint will be closed as a confirmation complaint and the complaint will be re-opened when the defect sample is acquired.;2023-09-22 08:53:02: after checked the defective sample, the defect is confirmed that the filament at the front end of the product broken.Further confirmed the production records and inspection records as well as the retention samples of this batch, no simi lar abnormality was found.After further review the complaint history of this batch product, no any complaint has been fed back.Besides, the batch code of this product is m8186h, and the corresponding production date is early jul 2018, it's been more than five years, which has exceeded the shelf life of this product (shelf life is 5 years).Based on the above, it is not ruled out that the product defect caused by long term exposure to illumination or other reasons, which is not related with the[?]manufacturing process.; response to consumer (if applicable): complaint conclusion: unsubstantiated.Investigation completion date: 2023-09-22 08:53:02.
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Manufacturer Narrative
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Argus case: (b)(4).
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Search Alerts/Recalls
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