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| Lot Number AL7249 |
| Device Problems
Use of Device Problem (1670); Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)
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| Patient Problems
Skin Inflammation (2443); Skin Tears (2516)
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Event Type
Injury
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Manufacturer Narrative
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Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event/serious/unknown.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: site notification date: 20aug2016 through 20aug2019/manufacturing site: pfizer albany/complaint class: external cause investigation / complaint sub class: adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The citi customizable search returned a total of 359 complaints for neck/shoulder/wrist (nsw) 8hr products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The subclasses show an increase in november 2018 thru jan2019.This is a seasonality change in combination with a change in safety¿s procedure wsr cp001 wi 110, ¿case processing principles product quality complaint guidance¿, updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting.
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Event Description
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Been experiencing skin sores [skin lesion] , been experiencing skin sores; it happened on both ends where the tape touched her skin; have you changed the formula for the sticky part? [device adhesion issue], use the neck/shoulder wraps for my lower back [device use issue].Case narrative:this is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), from an unspecified date at an unspecified frequency for her lower back.The patient medical history and concomitant medications were not reported.The patient had been purchasing thermacare heat wraps for her back for years and only last few months had been experiencing skin sores when she removed them gently.The patient wore them for about 6-8 hours as directed.She used the neck/shoulder wraps for her lower back on an unspecified date.It happened on both ends where the tape touched her skin.It happened a few times already, which was unusual.The patient asked, "have you changed the formula for the sticky part? i have a photo but no where to submit or attach in the form".The action taken in response to the events for thermacare heatwrap was unknown.The events outcome was unknown.According to product quality complaint group: conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event/serious/unknown.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: site notification date: 20aug2016 through 20aug2019/manufacturing site: (b)(4)/complaint class: external cause investigation / complaint sub class: adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The citi customizable search returned a total of 359 complaints for neck/shoulder/wrist (nsw) 8hr products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The subclasses show an increase in november 2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from apr2019.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in april and may2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.These complaints are classified as an open-pouch.All open pouch complaints are investigated per investigation memo cd-66388 and are not valid adverse events.Based on this citi customizable search for the subclasses of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for nsw products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for nsw 8hr product, refer to attachment unknown nsw 8hr ae serious unknown aug2016 to aug2019.Severity of harm: s3.Follow-up (15aug2019): follow-up attempts are completed.No further information is expected.Follow-up (16aug2019 and 31aug2019): new information received from a product quality complaint group included: severity of harm and investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (03jun2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events of "skin lesion" and "device adhesion issue" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "skin lesion" and "device adhesion issue" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device.
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Manufacturer Narrative
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Summary of investigation: batch al7249 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion for subclass adverse event safety request for investigation and adverse event/serious/unknown: the root cause category is non assignable (complaint not confirmed).The consumer states she has "been experiencing skin sores when i remove them gently.Where the tape touches my skin".After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the consumer has been experiencing skin sores.Where the tape touches her body is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.A return sample was received at the site for evaluation; however sample showed no obvious defects and was not confirmed as a manufacturing quality defect.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.For subclass adverse event safety request for investigation: lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the eighth complaint for the sub class adverse event safety request for investigation received at the (site name) requiring an evaluation for this batch.The previous complaints was not confirmed to have a manufacturing root cause for the complaint.The complaint was evaluated to identify any potential trend for the lot and subclass.On the basis of this evaluation, a trend does not exist for this batch.For subclass adverse event/serious/unknown: lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the (site name) requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.Refer to the 24-month trend chart attachment muscle and joint adverse event 03 jun 2017 to 03 jun 2019.Site sample status was received at the site.Return sample evaluation: 1 wrap inside sealed pouch.Pouch is sealed.No obvious defects.Carton not returned.
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Event Description
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Event verbatim [preferred term] been experiencing skin sores [skin lesion], been experiencing skin sores; it happened on both ends where the tape touched her skin; have you changed the formula for the sticky part? [device adhesion issue], use the neck/shoulder wraps for my lower back [device use issue], , narrative: this is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), lot number: al7249, expiry date: dec2021, from an unspecified date at an unspecified frequency for her lower back.The patient medical history and concomitant medications were not reported.The patient had been purchasing thermacare heat wraps for her back for years and only last few months had been experiencing skin sores when she removed them gently.The patient wore them for about 6-8 hours as directed.She used the neck/shoulder wraps for her lower back on an unspecified date.It happened on both ends where the tape touched her skin.It happened a few times already, which was unusual.The patient asked, "have you changed the formula for the sticky part? i have a photo but no where to submit or attach in the form".The action taken in response to the events for thermacare heatwrap was unknown.The events outcome was unknown.According to the product quality complaint group: severity of harm was provided as s3.Summary of investigation: batch al7249 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion for subclass adverse event safety request for investigation and adverse event/serious/unknown: the root cause category is non assignable (complaint not confirmed).The consumer states she has "been experiencing skin sores when i remove them gently.Where the tape touches my skin".After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the consumer has been experiencing skin sores.Where the tape touches her body is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.A return sample was received at the site for evaluation; however sample showed no obvious defects and was not confirmed as a manufacturing quality defect.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.For subclass adverse event safety request for investigation: lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the eighth complaint for the sub class adverse event safety request for investigation received at the (site name) requiring an evaluation for this batch.The previous complaints was not confirmed to have a manufacturing root cause for the complaint.The complaint was evaluated to identify any potential trend for the lot and subclass.On the basis of this evaluation, a trend does not exist for this batch.For subclass adverse event/serious/unknown: lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the (site name) requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.Refer to the 24-month trend chart attachment muscle and joint adverse event (b)(6) 2017 to (b)(6) 2019.Site sample status was received at the site.Return sample evaluation: 1 wrap inside sealed pouch.Pouch is sealed.No obvious defects.Carton not returned.Follow-up (b)(6) 2019 and (b)(6) 2019: new information received from a product quality complaint group included: severity of harm and investigation results.Follow-up (b)(6) 2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (b)(6) 2020: new information received from the product quality complaint group included product lot number, expiry date and additional investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (b)(6)2020: new information received from the product quality complaint group included return sample received by site, additional investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (b)(6) 2020: new information received from the product quality complaint group included additional investigational results for subclass adverse event/serious/unknown.Follow-up attempts are completed.No further information is expected.
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Event Description
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Event verbatim [preferred term] been experiencing skin sores [skin lesion], been experiencing skin sores; it happened on both ends where the tape touched her skin; have you changed the formula for the sticky part? [device adhesion issue], use the neck/shoulder wraps for my lower back [device use issue], , narrative: this is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), lot number: al7249, expiry date: dec2021, from an unspecified date at an unspecified frequency for her lower back.The patient medical history and concomitant medications were not reported.The patient had been purchasing thermacare heat wraps for her back for years and only last few months had been experiencing skin sores when she removed them gently.The patient wore them for about 6-8 hours as directed.She used the neck/shoulder wraps for her lower back on an unspecified date.It happened on both ends where the tape touched her skin.It happened a few times already, which was unusual.The patient asked, "have you changed the formula for the sticky part? i have a photo but no where to submit or attach in the form".The action taken in response to the events for thermacare heatwrap was unknown.The events outcome was unknown.According to product quality complaint group: conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event/serious/unknown.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: site notification date: 20aug2016 through 20aug2019/manufacturing site: pfizer albany/complaint class: external cause investigation / complaint sub class: adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The citi customizable search returned a total of 359 complaints for neck/shoulder/wrist (nsw) 8hr products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The subclasses show an increase in november 2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from apr2019.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in april and may2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.These complaints are classified as an open-pouch.All open pouch complaints are investigated per investigation memo cd-66388 and are not valid adverse events.Based on this citi customizable search for the subclasses of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for nsw products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for nsw 8hr product, refer to attachment unknown nsw 8hr ae serious unknown aug2016 to aug2019.Severity of harm: s3.According to the product quality complaint group: summary of investigation: batch al7249 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.The root cause category is non assignable (complaint not confirmed).The consumer states she has "been experiencing skin sores when i remove them gently.Where the tape touches my skin".After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the consumer has been experiencing skin sores.Where the tape touches her body is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Evaluation of return sample shows no obvious defects to the wrap.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the eighth complaint for the sub class adverse event safety request for investigation received at the (site name) requiring an evaluation for this batch.The previous complaints was not confirmed to have a manufacturing root cause for the complaint.The complaint was evaluated to identify any potential trend for the lot and subclass.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was received at the site.Return sample evaluation: 1 wrap inside sealed pouch.Pouch is sealed.No obvious defects.Carton not returned.Follow-up (16aug2019 and 31aug2019): new information received from a product quality complaint group included: severity of harm and investigation results.Follow-up (03jun2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (08jun2020): new information received from the product quality complaint group included product lot number, expiry date and additional investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (11jun2020): new information received from the product quality complaint group included return sample received by site, additional investigational results.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event/serious/unknown.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: site notification date: 20aug2016 through 20aug2019/manufacturing site: pfizer albany/complaint class: external cause investigation / complaint sub class: adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The citi customizable search returned a total of 359 complaints for neck/shoulder/wrist (nsw) 8hr products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The subclasses show an increase in november 2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from apr2019.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in april and may2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.These complaints are classified as an open-pouch.All open pouch complaints are investigated per investigation memo cd-66388 and are not valid adverse events.Based on this citi customizable search for the subclasses of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for nsw products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for nsw 8hr product, refer to attachment unknown nsw 8hr ae serious unknown aug2016 to aug2019.Summary of investigation: batch al7249 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.The root cause category is non assignable (complaint not confirmed).The consumer states she has "been experiencing skin sores when i remove them gently.Where the tape touches my skin".After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the consumer has been experiencing skin sores.Where the tape touches her body is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Evaluation of return sample shows no obvious defects to the wrap.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the eighth complaint for the sub class adverse event safety request for investigation received at the (site name) requiring an evaluation for this batch.The previous complaints was not confirmed to have a manufacturing root cause for the complaint.The complaint was evaluated to identify any potential trend for the lot and subclass.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was received at the site.Return sample evaluation: 1 wrap inside sealed pouch.Pouch is sealed.No obvious defects.Carton not returned.
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Manufacturer Narrative
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The root cause category is non assignable (complaint not confirmed).The consumer states she has "been experiencing skin sores when i remove them gently.Where the tape touches my skin".After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the consumer has been experiencing skin sores.Where the tape touches her body is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the fifth complaint for the sub class adverse event safety request for investigation received at the (site name) requiring an evaluation for this batch.The previous complaints was not confirmed to have a manufacturing root cause for the complaint.The complaint was evaluated to identify any potential trend for the lot and subclass.
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Event Description
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Event verbatim [preferred term] been experiencing skin sores [skin lesion], been experiencing skin sores; it happened on both ends where the tape touched her skin; have you changed the formula for the sticky part? [device adhesion issue], use the neck/shoulder wraps for my lower back [device use issue], , narrative: this is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), lot number: al7249, expiry date: dec2021, from an unspecified date at an unspecified frequency for her lower back.The patient medical history and concomitant medications were not reported.The patient had been purchasing thermacare heat wraps for her back for years and only last few months had been experiencing skin sores when she removed them gently.The patient wore them for about 6-8 hours as directed.She used the neck/shoulder wraps for her lower back on an unspecified date.It happened on both ends where the tape touched her skin.It happened a few times already, which was unusual.The patient asked, "have you changed the formula for the sticky part? i have a photo but no where to submit or attach in the form".The action taken in response to the events for thermacare heatwrap was unknown.The events outcome was unknown.According to product quality complaint group: conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event/serious/unknown.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: site notification date: 20aug2016 through 20aug2019/manufacturing site: pfizer albany/complaint class: external cause investigation / complaint sub class: adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The citi customizable search returned a total of 359 complaints for neck/shoulder/wrist (nsw) 8hr products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The subclasses show an increase in november 2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from apr2019.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in april and may2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.These complaints are classified as an open-pouch.All open pouch complaints are investigated per investigation memo cd-66388 and are not valid adverse events.Based on this citi customizable search for the subclasses of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for nsw products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for nsw 8hr product, refer to attachment unknown nsw 8hr ae serious unknown aug2016 to aug2019.Severity of harm: s3.According to the product quality complaint group on 08jun2020: the root cause category is non assignable (complaint not confirmed).The consumer states she has "been experiencing skin sores when i remove them gently.Where the tape touches my skin".After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the consumer has been experiencing skin sores.Where the tape touches her body is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the fifth complaint for the sub class adverse event safety request for investigation received at the (site name) requiring an evaluation for this batch.The previous complaints was not confirmed to have a manufacturing root cause for the complaint.The complaint was evaluated to identify any potential trend for the lot and subclass.Site sample status was not received.Follow-up (16aug2019 and 31aug2019): new information received from a product quality complaint group included: severity of harm and investigation results.Follow-up (03jun2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (08jun2020): new information received from the product quality complaint group included product lot number, expiry date and additional investigational results.Follow-up attempts are completed.No further information is expected.
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Search Alerts/Recalls
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