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| Lot Number AL8679 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Pain (1994); Tissue Damage (2104); Burn, Thermal (2530)
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| Event Date 01/27/2020 |
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Event Type
Injury
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Event Description
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Pad burned my skin off [thermal burn], pad burned my skin off [skin exfoliation].Case narrative: this is a spontaneous report from a contactable consumer reporting for herself.This female consumer of unknown age started to receive thermacare heatwrap (thermacare menstrual) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.Consumer stated the pad burned her skin off.She had used these heating pad since she was (b)(6) years old and never experienced such pain.She didn't expect this to happen.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "burned her skin off" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events of "burned her skin off" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term]: pad burned my skin off [thermal burn], pad burned my skin off [skin exfoliation].Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A female patient of an unknown age started to use thermacare heatwrap (thermacare menstrual) (device lot number al8679, expiration date dec2021) on an unknown date for an unknown indication.Relevant medical history and concomitant medications were not reported.The patient stated the pad burned her skin off.She had used these heating pads since she was 17 years old and never experienced such pain.She didn't expect this to happen.The action taken with thermacare heatwrap in response to the events and the clinical outcome of the events were unknown at the time of the report.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "burned her skin off" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.Follow-up (28jan2020): new information from the same contactable consumer reporting for herself included: device lot number and expiration date.Additional information has been requested and will be provided as it becomes available., comment: based on the information provided, the events of "burned her skin off" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] pad burned my skin off [thermal burn] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A 32-year-old female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number al8679, expiration date dec2021) on (b)(6) 2020 once a day for menstrual cramp.Relevant medical history was not reported.There were none concomitant medications.The patient stated the pad burned her skin off on (b)(6) 2020.She had used these heating pads since she was 17 years old and never experienced such pain.She didn't expect this to happen.She was on her mense.She usually used an electric pad but she was at work and was experiencing painful cramps.She had these in her locker from previous month and used for 6 hours.The patient was not hospitalized and did not receive any treatment in response to the event.The action taken with thermacare heatwrap in response to the event was permanently withdrawn on (b)(6)2020.The outcome of the event was resolved in 2020.Additional information has been requested and will be provided as it becomes available.Follow-up (b)(6) 2020): new information from the same contactable consumer reporting for herself included: device lot number and expiration date.Amendment: this follow-up report is being submitted to amend previously reported information: the event "skin exfoliation" was removed.Follow-up (b)(6) 2020): new information received from a contactable consumer includes: age, product indication, start date, stop date, action taken, none concomitant medications, event onset date, stop date, outcome.The patient was not hospitalized and did not receive any treatment in response to the event., comment: based on the information provided, the event of "burned her skin off" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] pad burned my skin off [thermal burn].Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A female patient of an unknown age started to use thermacare heatwrap (thermacare menstrual) (device lot number al8679, expiration date dec2021) on an unknown date for an unknown indication.Relevant medical history and concomitant medications were not reported.The patient stated the pad burned her skin off.She had used these heating pads since she was 17 years old and never experienced such pain.She didn't expect this to happen.The action taken with thermacare heatwrap in response to the events and the clinical outcome of the events were unknown at the time of the report.Additional information has been requested and will be provided as it becomes available.Follow-up (28jan2020): new information from the same contactable consumer reporting for herself included: device lot number and expiration date.Amendment: this follow-up report is being submitted to amend previously reported information: the event "skin exfoliation" was removed.Comment: based on the information provided, the event of "burned her skin off" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] pad burned my skin off [thermal burn].Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A 32-year-old female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number al8679, expiration date dec2021) on (b)(6) 2020 once a day for menstrual cramp.Relevant medical history was not reported.There were none concomitant medications.The patient stated the pad burned her skin off on (b)(6) 2020.She had used these heating pads since she was 17 years old and never experienced such pain.She didn't expect this to happen.She was on her mense.She usually used an electric pad but she was at work and was experiencing painful cramps.She had these in her locker from previous month and used for 6 hours.The patient was not hospitalized and did not receive any treatment in response to the event.The action taken with thermacare heatwrap in response to the event was permanently withdrawn on (b)(6) 2020.The outcome of the event was resolved in 2020.Additional information received from product quality complaint (pqc) group included investigation results.Summary of investigation: batch al8679 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap, "burned the skin off." the cause of the consumer stating the wrap caused a burn is inconclusive since review of records does not provide evidence to support defective product.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data 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.And rationale: an evaluation of the complaint history confirms that this is the six complaint for the sub class adverse serious unknown and adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaints has not been confirmed to have a manufacturing root cause related to the subclass.On the basis of this evaluation, a trend does not exist or exist for this batch.Expedite trend assmt.And rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.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 event negligible-minor.Site sample status was not received.Severity of harm was s3.Follow-up (28jan2020): new information from the same contactable consumer reporting for herself included: device lot number and expiration date.Amendment: this follow-up report is being submitted to amend previously reported information: the event "skin exfoliation" was removed.Follow-up (20mar2020): new information received from a contactable consumer includes: age, product indication, start date, stop date, action taken, none concomitant medications, event onset date, stop date, outcome.The patient was not hospitalized and did not receive any treatment in response to the event.Follow-up (26mar2020): new information received from a product quality complaint group includes: investigation results and severity rating.Comment: based on the information provided, the event of "burned her skin off" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Summary of investigation: batch al8679 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap, "burned the skin off." the cause of the consumer stating the wrap caused a burn is inconclusive since review of records does not provide evidence to support defective product.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data 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.And rationale: an evaluation of the complaint history confirms that this is the six complaint for the sub class adverse serious unknown and adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaints has not been confirmed to have a manufacturing root cause related to the subclass.On the basis of this evaluation, a trend does not exist or exist for this batch.Expedite trend assmt.And rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.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 event negligible-minor.Site sample status was not received.Severity of harm was s3.
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Manufacturer Narrative
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Summary of investigation: batch al8679 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap, "burned the skin off." the cause of the consumer stating the wrap caused a burn is inconclusive since review of records does not provide evidence to support defective product.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data 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.And rationale: an evaluation of the complaint history confirms that this is the six complaint for the sub class adverse serious unknown and adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaints has not been confirmed to have a manufacturing root cause related to the subclass.On the basis of this evaluation, a trend does not exist or exist for this batch.Expedite trend assmt.And rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.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 event negligible-minor.Site sample status was not received.Severity of harm was s3.Batch al8679 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed).The return sample evaluation does not show evidence of why the wrap burned the consumer.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap, "burned the skin off." the cause of the consumer stating the wrap caused a burn is inconclusive since review of records does not provide evidence to support defective product.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data 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 assessment and rationale: an evaluation of the complaint history confirms that this is the six complaint for the sub class adverse serious unknown and adverse event safety request for investigation received at the (site name withheld) requiring an evaluation for this batch.The previous complaints has not been confirmed to have a manufacturing root cause related to the subclass.On the basis of this evaluation, a trend does not exist or exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.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 event negligible-minor.Site sample status was received at the site.
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Event Description
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Event verbatim [preferred term]: pad burned my skin off [thermal burn], , narrative: this is a spontaneous report from a contactable consumer reporting for herself.A 32-year-old female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number al8679, expiration date dec2021) on (b)(6) 2020 once a day for menstrual cramp.Relevant medical history was not reported.There were none concomitant medications.The patient stated the pad burned her skin off on (b)(6) 2020.She had used these heating pads since she was 17 years old and never experienced such pain.She didn't expect this to happen.She was on her mense.She usually used an electric pad but she was at work and was experiencing painful cramps.She had these in her locker from previous month and used for 6 hours.The patient was not hospitalized and did not receive any treatment in response to the event.The action taken with thermacare heatwrap in response to the event was permanently withdrawn on (b)(6) 2020.The outcome of the event was resolved in 2020.Additional information received from product quality complaint (pqc) group on (b)(6) 2020 included investigation results.Summary of investigation: batch al8679 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap, "burned the skin off." the cause of the consumer stating the wrap caused a burn is inconclusive since review of records does not provide evidence to support defective product.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data 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.And rationale: an evaluation of the complaint history confirms that this is the six complaint for the sub class adverse serious unknown and adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaints has not been confirmed to have a manufacturing root cause related to the subclass.On the basis of this evaluation, a trend does not exist or exist for this batch.Expedite trend assmt.And rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.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 event negligible-minor.Site sample status was not received.Severity of harm was s3.According to product quality complaint group on (b)(6) 2020, batch al8679 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed).The return sample evaluation does not show evidence of why the wrap burned the consumer.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap, "burned the skin off." the cause of the consumer stating the wrap caused a burn is inconclusive since review of records does not provide evidence to support defective product.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data 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 assessment and rationale: an evaluation of the complaint history confirms that this is the six complaint for the sub class adverse serious unknown and adverse event safety request for investigation received at the (site name withheld) requiring an evaluation for this batch.The previous complaints has not been confirmed to have a manufacturing root cause related to the subclass.On the basis of this evaluation, a trend does not exist or exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.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 event negligible-minor.Site sample status was received at the site.Follow-up ((b)(6) 2020): new information from the same contactable consumer reporting for herself included: device lot number and expiration date.Amendment: this follow-up report is being submitted to amend previously reported information: the event "skin exfoliation" was removed.Follow-up ((b)(6) 2020): new information received from a contactable consumer includes: age, product indication, start date, stop date, action taken, none concomitant medications, event onset date, stop date, outcome.The patient was not hospitalized and did not receive any treatment in response to the event.Follow-up ((b)(6) 2020): new information received from a product quality complaint group includes: investigation results and severity rating.Follow up ((b)(6) 2020): follow up attempt completed, no further information expected.Follow-up ((b)(6) 2020): new information received from a product quality complaint group included: investigation result for returned sample.Follow-up attempts are completed.No further information is expected.
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Event Description
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Event verbatim [preferred term] pad burned my skin off [thermal burn].Narrative: this is a spontaneous report from a contactable consumer reporting for herself.A 32-year-old female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number al8679, expiration date dec2021) on (b)(6) 2020 once a day for menstrual cramp.Relevant medical history was not reported.There were none concomitant medications.The patient stated the pad burned her skin off on (b)(6) 2020.She had used these heating pads since she was 17 years old and never experienced such pain.She didn't expect this to happen.She was on her mense.She usually used an electric pad but she was at work and was experiencing painful cramps.She had these in her locker from previous month and used for 6 hours.The patient was not hospitalized and did not receive any treatment in response to the event.The action taken with thermacare heatwrap in response to the event was permanently withdrawn on (b)(6) 2020.The outcome of the event was resolved in 2020.Additional information received from product quality complaint (pqc) group on 26mar2020 included investigation results.Summary of investigation: batch al8679 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap, "burned the skin off." the cause of the consumer stating the wrap caused a burn is inconclusive since review of records does not provide evidence to support defective product.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data 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.And rationale: an evaluation of the complaint history confirms that this is the six complaint for the sub class adverse serious unknown and adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaints has not been confirmed to have a manufacturing root cause related to the subclass.On the basis of this evaluation, a trend does not exist or exist for this batch.Expedite trend assmt.And rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.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 event negligible-minor.Site sample status was not received.Severity of harm was s3.According to product quality complaint group on 27aug2020, batch al8679 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed).The return sample evaluation does not show evidence of why the wrap burned the consumer.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap, "burned the skin off." the cause of the consumer stating the wrap caused a burn is inconclusive since review of records does not provide evidence to support defective product.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data 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 second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.The previous investigations did not confirm to have a manufacturing root cause related to the subclass.Per (b)(4) compliant trending guideline, effective date: 24feb2020, the complaint was evaluated to identify a potential trend for the lot and subclass.Per (b)(4), a visual examination was performed to identify a potential trend.On the basis of this evaluation, a trend does not exist for this lot.Refer to attachment al8679 adverse event serious unknown.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of adverse event/serious/unknown.Refer to the 36 month trending chart attachment menstrual 8 hr adverse event serious unknown 28jan2018 to 08jan2020.Exped trend actions taken: there was deviation from (b)(6), complaint trending guidelines, effective 24feb2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in (b)(4), action item (b)(4).Site sample status: received at the site on 18feb2020.Return sample evaluation: two wraps - opened one of the two pouches.Wrap is normal, begin to heat.No defect found.Two pouches - (l) al8679 n, (b)(6); exp dec2021 00:33.Both pouches appear to have no defect.One carton - (l) al8679, (b)(6); exp dec2021 00:33.Carton opened by consumer.Follow-up (28jan2020): new information from the same contactable consumer reporting for herself included: device lot number and expiration date.Amendment: this follow-up report is being submitted to amend previously reported information: the event "skin exfoliation" was removed.Follow-up (20mar2020): new information received from a contactable consumer includes: age, product indication, start date, stop date, action taken, none concomitant medications, event onset date, stop date, outcome.The patient was not hospitalized and did not receive any treatment in response to the event.Follow-up (26mar2020): new information received from a product quality complaint group includes: investigation results and severity rating.Follow up (16apr2020): follow up attempt completed, no further information expected.Follow-up (27aug2020): new information received from a product quality complaint group included: investigation result for returned sample.Follow-up attempts are completed.No further information is expected.Follow-up (16oct2020): new information received from a product quality complaint group included: updated trend information.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Summary of investigation: batch al8679 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap, "burned the skin off." the cause of the consumer stating the wrap caused a burn is inconclusive since review of records does not provide evidence to support defective product.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data 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.And rationale: an evaluation of the complaint history confirms that this is the six complaint for the sub class adverse serious unknown and adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaints has not been confirmed to have a manufacturing root cause related to the subclass.On the basis of this evaluation, a trend does not exist or exist for this batch.Expedite trend assmt.And rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.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 event negligible-minor.Site sample status was not received.Severity of harm was s3.Batch al8679 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed).The return sample evaluation does not show evidence of why the wrap burned the consumer.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap, "burned the skin off." the cause of the consumer stating the wrap caused a burn is inconclusive since review of records does not provide evidence to support defective product.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data 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 second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.The previous investigations did not confirm to have a manufacturing root cause related to the subclass.Per (b)(4) compliant trending guideline, effective date: 24feb2020, the complaint was evaluated to identify a potential trend for the lot and subclass.Per (b)(4), a visual examination was performed to identify a potential trend.On the basis of this evaluation, a trend does not exist for this lot.Refer to attachment al8679 adverse event serious unknown.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of adverse event/serious/unknown.Refer to the 36 month trending chart attachment menstrual 8 hr adverse event serious unknown 28jan2018 to 08jan2020.Exped trend actions taken: there was deviation from (b)(4), complaint trending guidelines, effective 24feb2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in (b)(4), action item (b)(4).Site sample status: received at the site on 18feb2020.Return sample evaluation: two wraps - opened one of the two pouches.Wrap is normal, begin to heat.No defect found.Two pouches - (l) al8679 n, (b)(6); exp dec2021 00:33.Both pouches appear to have no defect.One carton - (l) al8679, (b)(6); exp dec2021 00:33.Carton opened by consumer.
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Search Alerts/Recalls
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