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| Lot Number CM8994 |
| Device Problem
Device Dislodged or Dislocated (2923)
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| Patient Problem
Burn, Thermal (2530)
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Event Type
Injury
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Event Description
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Heatwrap got dislodged and it burned my skin [thermal burn], heatwrap got dislodged and it burned my skin [device issue], narrative: this is a spontaneous report from a contactable consumer or other non healthcare professional (reporting on himself).A male patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), product lot (batch number): cm8994, expiry: jul2023, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient burnt himself with the thermacare advanced neck pain.He used the product two nights in a row.When he used it the 2nd night the heatwrap got dislodged and it burned his skin.The patient already talked to his general practitioner.The action taken in response to the event for thermacare heatwrap and the event outcome were unknown.The patient had a sample available for return.Additional information has been requested and will be provided as it becomes available.
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Manufacturer Narrative
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Severity of harm was s3.Albany summary investigation details report for complaint class 'external cause investigation', summary of investigations: batch cm8994 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: 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 "i burnt myself with the thermacare advanced neck pain." 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.Root cause was not confirmed.Trending information: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.Sample was not received for investigation.Albany summary investigation details report for complaint class 'product use attributes': summary of investigation: batch cm8994 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: the root cause category is non-assignable and complaint can not be confirmed as a quality defect.A return sample is not available by the site for evaluation to confirm a manufacturing quality defect.The consumer reports burns to the skin.The cause of the consumers burns is inconclusive since review of records does not provide evidence to support a defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of skin irritation.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.After a review of the batch thermal records, thermal data results show all wraps met the required wrap batch average temperatures.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.Root cause: complaint not confirmed.Lot trend: an evaluation of the complaint history confirms that this is the first complaint for the subclass wrap/patch/pad too hot received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.Per (b)(4), complaint trending guideline, effective 24feb2020, a visual evaluation was performed to identify a potential trend for the subclass.On this basis, a trend does not exist for this batch.Return sample was not received.
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Event Description
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Event verbatim [preferred term] heatwrap got dislodged and it burned my skin [thermal burn], heatwrap got dislodged and it burned my skin [device issue].Narrative: this is a spontaneous report from a contactable consumer (reporting on himself).A male patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), product lot (batch number): cm8994, expiry: 30jun2022, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient burnt himself with the thermacare advanced neck pain.He used the product two nights in a row.When he used it the 2nd night the heatwrap got dislodged and it burned his skin.The patient already talked to his general practitioner.The action taken in response to the event for thermacare heatwrap and the event outcome were unknown.The patient had a sample available for return.According to product quality complaint group, severity of harm was s3.Albany summary investigation details report for complaint class 'external cause investigation', summary of investigations: batch cm8994 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: 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 "i burnt myself with the thermacare advanced neck pain." 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.Root cause was not confirmed.Trending information: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.Sample was not received for investigation.Albany summary investigation details report for complaint class 'product use attributes': summary of investigation: batch cm8994 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: the root cause category is non-assignable and complaint can not be confirmed as a quality defect.A return sample is not available by the site for evaluation to confirm a manufacturing quality defect.The consumer reports burns to the skin.The cause of the consumers burns is inconclusive since review of records does not provide evidence to support a defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of skin irritation.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.After a review of the batch thermal records, thermal data results show all wraps met the required wrap batch average temperatures.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.Root cause: complaint not confirmed.Lot trend: an evaluation of the complaint history confirms that this is the first complaint for the subclass wrap/patch/pad too hot received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.Per (b)(4), complaint trending guideline, effective 24feb2020, a visual evaluation was performed to identify a potential trend for the subclass.On this basis, a trend does not exist for this batch.Return sample was not received.Follow-up (30jul2020): new information received from product quality complaint group includes investigation result and updated expiration date.
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Manufacturer Narrative
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Albany summary investigation details report for complaint sub class adverse event/serious/unknown, severity of harm was s3.Summary of investigations: batch cm8994 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: 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 "i burnt myself with the thermacare advanced neck pain." 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.Root cause was not confirmed.Trending information: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.Sample was not received for investigation.Albany summary investigation details report for complaint subclass adhesion/fastening defect: severity of harm was s1.Summary of investigation: batch cm8994 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: the root cause category is non assignable (complaint not confirmed as a quality defect).The consumer reports "heatwrap got dislodged." the cause of the consumer reporting "heatwrap got dislodged" is inconclusive since review of records does not provide evidence to support a defective product.Sample is not available for evaluation by the site; complaint cannot be confirmed.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 wrap became dislodged 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.Root cause/capa: process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the fourth complaint for the sub class adhesion/fastening defect received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.
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Event Description
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Event verbatim [preferred term]: heatwrap got dislodged and it burned my skin [thermal burn], heatwrap got dislodged and it burned my skin [device issue], , narrative: this is a spontaneous report from a contactable consumer (reporting on himself).A male patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number: cm8994, expiry date: 30jun2022, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient burnt himself with the thermacare advanced neck pain.He used the product two nights in a row.When he used it the 2nd night the heatwrap got dislodged and it burned his skin.The patient already talked to his general practitioner.The action taken in response to the event for thermacare heatwrap and the event outcome were unknown.The patient had a sample available for return.According to product quality complaint group, albany summary investigation details report for complaint sub class adverse event/serious/unknown, severity of harm was s3.Summary of investigations: batch cm8994 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: 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 "i burnt myself with the thermacare advanced neck pain." 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.Root cause was not confirmed.Trending information: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.Sample was not received for investigation.Albany summary investigation details report for complaint subclass adhesion/fastening defect: severity of harm was s1.Summary of investigation: batch cm8994 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: the root cause category is non assignable (complaint not confirmed as a quality defect).The consumer reports "heatwrap got dislodged." the cause of the consumer reporting "heatwrap got dislodged" is inconclusive since review of records does not provide evidence to support a defective product.Sample is not available for evaluation by the site; complaint cannot be confirmed.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 wrap became dislodged 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.Root cause/capa: process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the fourth complaint for the sub class adhesion/fastening defect received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.Follow-up (30jul2020) 2020): new information received from product quality complaint group includes investigation result and updated expiration date.Follow-up (17aug2020): follow-up attempts are completed.No further information is expected.Follow up (08oct2020): new information received from the product quality complaint group includes updated trend information.Follow-up attempts are completed.No further information is expected.Follow up (21dec2020): new information received from the product quality complaint group includes investigational results for complaint subclass wrap/patch/pad too hot updated to investigational results for complaint subclass adhesion/fastening defect.
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Event Description
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Event verbatim [preferred term].Heatwrap got dislodged and it burned my skin [thermal burn], heatwrap got dislodged and it burned my skin [device issue], , narrative: this is a spontaneous report from a contactable consumer (reporting on himself).A male patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number: cm8994, expiry date: 30jun2022, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient burnt himself with the thermacare advanced neck pain.He used the product two nights in a row.When he used it the 2nd night the heatwrap got dislodged and it burned his skin.The patient already talked to his general practitioner.The action taken in response to the event for thermacare heatwrap and the event outcome were unknown.The patient had a sample available for return.According to product quality complaint group, severity of harm was s3.Albany summary investigation details report for complaint class 'external cause investigation', summary of investigations: batch cm8994 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: 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 "i burnt myself with the thermacare advanced neck pain." 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.Root cause was not confirmed.Trending information: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.Sample was not received for investigation.Albany summary investigation details report for complaint class 'product use attributes': summary of investigation: batch cm8994 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: the root cause category is non-assignable and complaint can not be confirmed as a quality defect.A return sample is not available by the site for evaluation to confirm a manufacturing quality defect.The consumer reports burns to the skin.The cause of the consumers burns is inconclusive since review of records does not provide evidence to support a defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of skin irritation.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.After a review of the batch thermal records, thermal data results show all wraps met the required wrap batch average temperatures.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.Root cause: complaint not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the subclass wrap/patch/pad too hot received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.Per sop-105746, complaint trending guideline, effective (b)(6) 2020, a visual evaluation was performed to identify a potential trend for the subclass.On this basis, a trend does not 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 customizable citi search, a trend does not exist for the subclass wrap/patch/pad too hot for nsw 12hr products for this lot.Refer to the 36-month trend chart attachment wrap-patch-pad too hot nsw 12hr (b)(6) 2017 to (b)(6) 2020.There was deviation from sop-105746, complaint trending guidelines, effective (b)(6) 2020 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).Return sample was not received.Follow-up (30jul2020): new information received from product quality complaint group includes investigation result and updated expiration date.Follow-up (17aug2020): follow-up attempts are completed.No further information is expected.Follow up (08oct2020): new information received from the product quality complaint group includes updated trend information.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Severity of harm was s3.Albany summary investigation details report for complaint class 'external cause investigation', summary of investigations: batch cm8994 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: 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 "i burnt myself with the thermacare advanced neck pain." 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.Root cause was not confirmed.Trending information: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.Sample was not received for investigation.Albany summary investigation details report for complaint class 'product use attributes': summary of investigation: batch cm8994 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: the root cause category is non-assignable and complaint can not be confirmed as a quality defect.A return sample is not available by the site for evaluation to confirm a manufacturing quality defect.The consumer reports burns to the skin.The cause of the consumers burns is inconclusive since review of records does not provide evidence to support a defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of skin irritation.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.After a review of the batch thermal records, thermal data results show all wraps met the required wrap batch average temperatures.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.Root cause: complaint not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the subclass wrap/patch/pad too hot received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.Per sop-105746, complaint trending guideline, effective (b)(6) 2020, a visual evaluation was performed to identify a potential trend for the subclass.On this basis, a trend does not 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 customizable citi search, a trend does not exist for the subclass wrap/patch/pad too hot for nsw 12hr products for this lot.Refer to the 36-month trend chart attachment wrap-patch-pad too hot nsw 12hr (b)(6) 2017 to (b)(6) 2020.There was deviation from sop-105746, complaint trending guidelines, effective (b)(6) 2020 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).Return sample was not received.
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Event Description
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Event verbatim [preferred term] heatwrap got dislodged and it burned my skin [thermal burn], heatwrap got dislodged and it burned my skin [device issue], , narrative: this is a spontaneous report from a contactable consumer (reporting on himself).A male patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number: cm8994, expiry date: 30jun2022, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient burnt himself with the thermacare advanced neck pain.He used the product two nights in a row.When he used it the 2nd night the heatwrap got dislodged and it burned his skin.The patient already talked to his general practitioner.The action taken in response to the event for thermacare heatwrap and the event outcome were unknown.The patient had a sample available for return.According to product quality complaint group, albany summary investigation details report for complaint sub class adverse event/serious/unknown, severity of harm was s3.Summary of investigations: batch cm8994 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: 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 "i burnt myself with the thermacare advanced neck pain." 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.Root cause was not confirmed.Trending information: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.Sample was not received for investigation.Albany summary investigation details report for complaint subclass adhesion/fastening defect: severity of harm was s1.Summary of investigation: batch cm8994 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: the root cause category is non assignable (complaint not confirmed as a quality defect).The consumer reports "heatwrap got dislodged." the cause of the consumer reporting "heatwrap got dislodged" is inconclusive since review of records does not provide evidence to support a defective product.Sample is not available for evaluation by the site; complaint cannot be confirmed.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 wrap became dislodged 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.Root cause/capa: process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the fourth complaint for the sub class adhesion/fastening defect received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.Follow-up (30jul2020): new information received from product quality complaint group includes investigation result and updated expiration date.Follow-up (17aug2020): follow-up attempts are completed.No further information is expected.Follow up (08oct2020): new information received from the product quality complaint group includes updated trend information.Follow-up attempts are completed.No further information is expected.Follow up (21dec2020): new information received from the product quality complaint group includes investigational results for complaint subclass wrap/patch/pad too hot updated to investigational results for complaint subclass adhesion/fastening defect.Amendment: this follow-up report is being submitted to amend previously reported information: update number of similar incidents and number of devices on market.
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Manufacturer Narrative
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Albany summary investigation details report for complaint sub class adverse event/serious/unknown, severity of harm was s3.Summary of investigations: batch cm8994 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: 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 "i burnt myself with the thermacare advanced neck pain." 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.Root cause was not confirmed.Trending information: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.Sample was not received for investigation.Albany summary investigation details report for complaint subclass adhesion/fastening defect: severity of harm was s1.Summary of investigation: batch cm8994 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: the root cause category is non assignable (complaint not confirmed as a quality defect).The consumer reports "heatwrap got dislodged." the cause of the consumer reporting "heatwrap got dislodged" is inconclusive since review of records does not provide evidence to support a defective product.Sample is not available for evaluation by the site; complaint cannot be confirmed.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 wrap became dislodged 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.Root cause/capa: process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the fourth complaint for the sub class adhesion/fastening defect received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.
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Search Alerts/Recalls
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