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| Lot Number CN6723 |
| Device Problems
Overheating of Device (1437); Short Fill (1575); Use of Device Problem (1670); Excessive Heating (4030)
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| Patient Problems
Burning Sensation (2146); Burn, Thermal (2530)
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| Event Date 01/01/2019 |
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Event Type
Injury
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Event Description
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Burning of skin [skin burning sensation], heatwrap got too hot when applied [device issue], now he uses the wrap directly on his skin [intentional device misuse].Case narrative: this is a spontaneous report from a contactable consumer reporting for himself.This (b)(6) male consumer started to use thermacare heatwrap (thermacare lower back & hip) (device lot number cn6723, expiration date jul2022, udi number# (b)(4)) from an unspecified date for issue with back and sciatic in right leg.Relevant medical history was none.Relevant concomitant medications included general vitamins, in the morning and after dinner, well before he retires for the night.No further details provided.Consumer also reported he used a wrap alternately with salonpas, he uses one or the other every night.Consumer reported has been using thermacare heatwraps for 3-4 years, and now he uses the wrap directly on his skin, he has always done this with no problems.Consumer reported he uses one wrap to his skin as needed.Consumer reported he had a 2 wraps box and he used one heatwrap in the box with success.He stated that the second heatwrap got too hot when applied on (b)(6) 2020, so he removed it immediately to avoid being burned, as soon as he experienced the burning of his skin.Consumer had completely recovered at the time of this report and there was no damage, the wrap just got too hot.Consumer removed wrap and saved it with the pouch and the box, however he did not save and discarded the box.He was calling to ask for a refund because it is the first time he ever had any burning.He does attend an ortho doctor, the one who recommended him the product.A sample of the product is available.There was no action taken with thermacare heatwraps, the product was ongoing.The outcome of the events "heatwrap got too hot when applied" "burning of skin" was resolved in (b)(6) 2020.The outcome of the other event 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 report of "uses the wrap directly on his skin, the wrap just got too hot, and burning of his skin" as described is considered serious potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.Comment: based on the information provided, the report of "uses the wrap directly on his skin, the wrap just got too hot, and burning of his skin" as described is considered serious potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.
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Manufacturer Narrative
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Summary of investigation: batch cn6723 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "got too hot ".The cause of the consumer stating the wrap was too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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 first complaint for the sub class wrap/patch/pad too hot for this batch.On the basis of this evaluation, a trend does not exist for this batch.The sample had not been received by the site.
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Event Description
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Event verbatim [preferred term] burning of skin [skin burning sensation] , heatwrap got too hot when applied [device issue] , now he uses the wrap directly on his skin [intentional device misuse].Case narrative:this is a spontaneous report from a contactable consumer reporting for himself.This 83-year-old male consumer started to use thermacare heatwrap (thermacare lower back & hip) (device lot number cn6723, expiration date jul2022, udi number# (b)(4)) from an unspecified date for 3-4 years for issue with back and sciatic in right leg.Relevant medical history was none.Relevant concomitant medications included general vitamins, in the morning and after dinner, well before he retires for the night.No further details provided.Consumer also reported he used a wrap alternately with salonpas, he used one or the other every night.Consumer reported has been using thermacare heatwraps for 3-4 years, and now he used the wrap directly on his skin, he has always done this with no problems.Consumer reported he used one wrap to his skin as needed.Consumer reported he had a 2 wraps box and he used one heatwrap in the box with success.He stated that the second heatwrap got too hot when applied on (b)(6)2020, so he removed it immediately to avoid being burned, as soon as he experienced the burning of his skin.Consumer had completely recovered at the time of this report and there was no damage, the wrap just got too hot.Consumer removed wrap and saved it with the pouch and the box, however he did not save and discarded the box.He was calling to ask for a refund because it is the first time he ever had any burning.He did attend an ortho doctor, the one who recommended him the product.A sample of the product was available.There was no action taken with thermacare heatwraps, the product was ongoing.The outcome of the events "heatwrap got too hot when applied" "burning of skin" was resolved in (b)(6)2020.The outcome of the other event was unknown.According to product quality complaint group: summary of investigation: batch cn6723 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "got too hot ".The cause of the consumer stating the wrap was too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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 first complaint for the sub class wrap/patch/pad too hot for this batch.On the basis of this evaluation, a trend does not exist for this batch.The sample had not been received by the site.Follow-up (06feb2020): new information received from a product quality complaint group included: investigation results.Company clinical evaluation comment based on the information provided, the report of "uses the wrap directly on his skin, the wrap just got too hot, and burning of his skin" as described is considered serious potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.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.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the report of "uses the wrap directly on his skin, the wrap just got too hot, and burning of his skin" as described is considered serious potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.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.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.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 cn6723 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "got too hot ".The cause of the consumer stating the wrap was too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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 first complaint for the sub class wrap/patch/pad too hot for this batch.On the basis of this evaluation, a trend does not exist for this batch.The sample had not been received by the site.
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Event Description
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Event verbatim [preferred term]: burning of skin [skin burning sensation], heatwrap got too hot when applied [device issue], now he uses the wrap directly on his skin/kept on back throughout the night until awakening in the morning [intentional device misuse].Case narrative:this is a spontaneous report from a contactable consumer reporting for himself.This 82-year-old male consumer started to use thermacare heatwrap (thermacare lower back & hip) (device lot number cn6723, expiration date jul2022, udi number# (b)(4)) from (b)(6) 2019 for issue with back, sciatic in right leg, spinal stenosis thoracic region.Relevant medical history was none.Relevant concomitant medications included general vitamins, in the morning and after dinner, well before he retires for the night.No further details provided.Consumer also reported he used a wrap alternately with salonpas.He applied heat wrap every night upon retiring and kept on back throughout the night until awakening in the morning since (b)(6) 2019.He has done this for over a year with no similar burning.Consumer reported now he used the wrap directly on his skin, he has always done this with no problems.Consumer reported he used one wrap to his skin as needed.Consumer reported he had a 2 wraps box and he used one heatwrap in the box with success.He stated that the second heatwrap got too hot when applied on (b)(6) 2020, so he removed it immediately to avoid being burned, as soon as he experienced the burning of his skin.Consumer had completely recovered at the time of this report and there was no damage, no admission to hospital involved and no treatment received: the wrap just got too hot.Consumer removed wrap and saved it with the pouch and the box, however he did not save and discarded the box.He was calling to ask for a refund because it is the first time he ever had any burning.He did attend an ortho doctor, the one who recommended him the product.A sample of the product was available.There was no action taken with thermacare heatwraps, the product was ongoing.The outcome of the events "heatwrap got too hot when applied" "burning of skin" was resolved in (b)(6) 2020.The outcome of the other event was unknown.According to product quality complaint group: summary of investigation: batch cn6723 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "got too hot ".The cause of the consumer stating the wrap was too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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 first complaint for the sub class wrap/patch/pad too hot for this batch.On the basis of this evaluation, a trend does not exist for this batch.The sample had not been received by the site.Follow-up (06feb2020): new information received from a product quality complaint group included: investigation results.Follow-up (13feb2020): new information from the contactable consumer includes: events skin burning sensation and device issue onset date updated from (b)(6) 2020 to (b)(6) 2020, no treatment or hospitalization were involved, event intentional device misuse onset date added as (b)(6) 2019, thermacare heatwrap start date and additional indication for use provided.Follow-up attempts are completed.No further information is expected.Comment: based on the information provided, the report of "uses the wrap directly on his skin, the wrap just got too hot, and burning of his skin" as described is considered serious potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.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.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Event Description
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Event verbatim [preferred term] heatwrap got too hot when applied [device issue] , now he uses the wrap directly on his skin/kept on back throughout the night until awakening in the morning [intentional device misuse], burning of skin [skin burning sensation] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for himself.This 82-year-old male consumer started to use thermacare heatwrap (thermacare lower back & hip) (device lot number cn6723, expiration date jul2022, udi number# (b)(4) from (b)(6) 2019 for issue with back, sciatic in right leg, spinal stenosis thoracic region.Relevant medical history was none.Relevant concomitant medications included general vitamins, in the morning and after dinner, well before he retires for the night.No further details provided.Consumer also reported he used a wrap alternately with salonpas.He applied heat wrap every night upon retiring and kept on back throughout the night until awakening in the morning since (b)(6) 2019.He has done this for over a year with no similar burning.Consumer reported now he used the wrap directly on his skin, he has always done this with no problems.Consumer reported he used one wrap to his skin as needed.Consumer reported he had a 2 wraps box and he used one heatwrap in the box with success.He stated that the second heatwrap got too hot when applied on (b)(6) 2020, so he removed it immediately to avoid being burned, as soon as he experienced the burning of his skin.Consumer had completely recovered at the time of this report and there was no damage, no admission to hospital involved and no treatment received: the wrap just got too hot.Consumer removed wrap and saved it with the pouch and the box, however he did not save and discarded the box.He was calling to ask for a refund because it is the first time he ever had any burning.He did attend an ortho doctor, the one who recommended him the product.A sample of the product was available.There was no action taken with thermacare heatwraps, the product was ongoing.The outcome of the events "heatwrap got too hot when applied" "burning of skin" was resolved in (b)(6) 2020.The outcome of the other event was unknown.According to product quality complaint group: summary of investigation: batch cn6723 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "got too hot ".The cause of the consumer stating the wrap was too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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 first complaint for the sub class wrap/patch/pad too hot for this batch.On the basis of this evaluation, a trend does not exist for this batch.The sample had not been received by the site.The severity of harm was s3.Follow-up (06feb2020): new information received from a product quality complaint group included: investigation results.Follow-up (13feb2020): new information from the contactable consumer includes: events skin burning sensation and device issue onset date updated from 27jan2020 to 03jan2020, no treatment or hospitalization were involved, event intentional device misuse onset date added as jan2019, thermacare heatwrap start date and additional indication for use provided.Follow-up attempts are completed.No further information is expected.Follow-up (25mar2020): new information received from product quality complaints included severity rating assessment.Follow-up attempts are completed.No further information is expected.Comment: based on the information provided, the report of "uses the wrap directly on his skin, the wrap just got too hot, and burning of his skin" as described is considered serious potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.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.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.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 cn6723 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "got too hot ".The cause of the consumer stating the wrap was too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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 first complaint for the sub class wrap/patch/pad too hot for this batch.On the basis of this evaluation, a trend does not exist for this batch.The sample had not been received by the site.
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Manufacturer Narrative
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Summary of investigation: batch cn6723 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "got too hot ".The cause of the consumer stating the wrap was too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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 first complaint for the sub class wrap/patch/pad too hot for this batch.On the basis of this evaluation, a trend does not exist for this batch.The sample had not been received by the site.Additional investigational results from the product quality complaint for complaint sub-class product container under-filled/short count on (b)(6) 2020: summary of investigation: batch cn6723 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 evaluation of the return sample does not confirm the complaint for short count.At the beginning of the production run for the batch, form -53504, b line reject verifications form, effective date: (b)(6) 2019 was completed to verify the check-weigher was operating correctly.This check was performed on (b)(6) 2019 and passed the reject verification criteria.A short count carton cannot be confirmed by the site once the carton has been opened.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.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 first complaint for the sub class product container under-filled/short count 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 received at the site on 11feb2020; return sample evaluation: 1 wrap: no obvious defect 1 pouch: (l) cn6723 08/09 exp 2022-07 16:05 wrap pouch opened by consumer 1 carton: (l) cn6723 08/09 exp 2022-07 16:07 carton opened by consumer.
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Event Description
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Event verbatim [preferred term].Now he uses the wrap directly on his skin/kept on back throughout the night until awakening in the morning [intentional device misuse], burning of skin [skin burning sensation], heatwrap got too hot when applied [device issue], use thermacare lower back & hip for issue with sciatic in right leg [device use issue].Narrative: this is a spontaneous report from a contactable consumer reporting for himself.This 82-year-old male consumer started to use thermacare heatwrap (thermacare lower back & hip) (device lot number cn6723, expiration date jul2022, udi number# (b)(4)) from (b)(6) 2019 for issue with back, sciatic in right leg, spinal stenosis thoracic region.Relevant medical history was none.Relevant concomitant medications included general vitamins, in the morning and after dinner, well before he retires for the night.Consumer also reported he used a wrap alternately with salonpas.He applied heat wrap every night upon retiring and kept on back throughout the night until awakening in the morning since (b)(6) 2019.He had done this for over a year with no similar burning.Consumer reported now he used the wrap directly on his skin, he has always done this with no problems.Consumer reported he used one wrap to his skin as needed.Consumer reported he had a 2 wraps box and he used one heatwrap in the box with success.He stated that the second heatwrap got too hot when applied on (b)(6) 2020, so he removed it immediately to avoid being burned, as soon as he experienced the burning of his skin.Consumer had completely recovered at the time of this report and there was no damage, no admission to hospital involved and no treatment received: the wrap just got too hot.Consumer removed wrap and saved it with the pouch and the box, however he did not save and discarded the box.He was calling to ask for a refund because it is the first time he ever had any burning.He did attend an ortho doctor, the one who recommended him the product.3-4 weeks ago, he at that point, received only one wrap in a box when he purchased it.A sample of the product was available.There was no action taken with thermacare heatwraps, the product was ongoing.The outcome of the events "heatwrap got too hot when applied" "burning of skin" was resolved in (b)(6) 2020.The outcome of the other events was unknown.According to product quality complaint group: summary of investigation: batch cn6723 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "got too hot ".The cause of the consumer stating the wrap was too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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 first complaint for the sub class wrap/patch/pad too hot for this batch.On the basis of this evaluation, a trend does not exist for this batch.The sample had not been received by the site.The severity of harm was s3.Additional investigational results from the product quality complaint for complaint sub-class product container under-filled/short count on (b)(6) 2020: summary of investigation: batch cn6723 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 evaluation of the return sample does not confirm the complaint for short count.At the beginning of the production run for the batch, form -53504, b line reject verifications form, effective date: (b)(6) 2019 was completed to verify the check-weigher was operating correctly.This check was performed on (b)(6) 2019 and passed the reject verification criteria.A short count carton cannot be confirmed by the site once the carton has been opened.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.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 first complaint for the sub class product container under-filled/short count 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 received at the site on 11feb2020; return sample evaluation: 1 wrap: no obvious defect 1 pouch: (l) cn6723 08/09 exp 2022-07 16:05 wrap pouch opened by consumer 1 carton: (l) cn6723 08/09 exp 2022-07 16:07 carton opened by consumer.Follow-up (06feb2020): new information received from a product quality complaint group included: investigation results.Follow-up (13feb2020): new information from the contactable consumer includes: events skin burning sensation and device issue onset date updated from (b)(6) 2020 to (b)(6) 2020, no treatment or hospitalization were involved, event intentional device misuse onset date added as (b)(6) 2019, thermacare heatwrap start date and additional indication for use provided.Follow-up attempts are completed.No further information is expected.Follow-up (25mar2020): new information received from product quality complaints included severity rating assessment.Follow-up attempts are completed.No further information is expected.Follow-up (29jul2020): this is a follow up report received from the product quality complaint group includes investigational results for complaint sub-class: product container under-filled/short count and event "use thermacare lower back & hip for issue with sciatic in right leg" added.No follow-up attempts are needed.No further information expected.
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Event Description
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Event verbatim [preferred term] now he uses the wrap directly on his skin/kept on back throughout the night until awakening in the morning [intentional device misuse], burning of skin [skin burning sensation], heatwrap got too hot when applied [device issue], use thermacare lower back & hip for issue with sciatic in right leg [device use issue], , narrative: this is a spontaneous report from a contactable consumer reporting for himself.This 82-year-old male consumer started to use thermacare heatwrap (thermacare lower back & hip) (device lot number cn6723, expiration date jul2022, udi number# (b)(4)) from (b)(6) 2019 for issue with back, sciatic in right leg, spinal stenosis thoracic region.Relevant medical history was none.Relevant concomitant medications included general vitamins, in the morning and after dinner, well before he retires for the night.Consumer also reported he used a wrap alternately with salonpas.He applied heat wrap every night upon retiring and kept on back throughout the night until awakening in the morning since (b)(6) 2019.He had done this for over a year with no similar burning.Consumer reported now he used the wrap directly on his skin, he has always done this with no problems.Consumer reported he used one wrap to his skin as needed.Consumer reported he had a 2 wraps box and he used one heatwrap in the box with success.He stated that the second heatwrap got too hot when applied on (b)(6) 2020, so he removed it immediately to avoid being burned, as soon as he experienced the burning of his skin.Consumer had completely recovered at the time of this report and there was no damage, no admission to hospital involved and no treatment received: the wrap just got too hot.Consumer removed wrap and saved it with the pouch and the box, however he did not save and discarded the box.He was calling to ask for a refund because it is the first time he ever had any burning.He did attend an ortho doctor, the one who recommended him the product.3-4 weeks ago, he at that point, received only one wrap in a box when he purchased it.A sample of the product was available.There was no action taken with thermacare heatwraps, the product was ongoing.The outcome of the events "heatwrap got too hot when applied" "burning of skin" was resolved in (b)(6) 2020.The outcome of the other events was unknown.According to product quality complaint group for complaint sub-class: wrap/patch/pad too hot: the severity of harm was s3.Summary of investigation: batch cn6723 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "got too hot ".The cause of the consumer stating the wrap was too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.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 first complaint for the sub class wrap/patch/pad too hot for this batch.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi customizable search for the subclasses of wrap/patch/pad too hot for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of wrap/patch/pad too hot for lbh product, refer to attachment wrap patch pad too hot lbh 29jan2017 to 29jan2020.This investigation was reopened to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from sop-#, complaint trending guidelines, effective dates 19nov2019 and 24feb2020.A notification of nonconformance was opened pr-#.This deviation will not change the conclusion of the investigation.Site sample status was received at the site on 11feb2020; return sample evaluation: 1 wrap: no obvious defect 1 pouch: (l) cn6723 09aug exp jul2022 16:05 wrap pouch opened by consumer 1 carton: (l) cn6723 09aug exp jul2022 16:07 carton opened by consumer.Additional investigational results from the product quality complaint for complaint sub-class product container under-filled/short count on 29jul2020: summary of investigation: batch cn6723 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 evaluation of the return sample does not confirm the complaint for short count.At the beginning of the production run for the batch, form -53504, b line reject verifications form, effective date: 06-may-2019 was completed to verify the check-weigher was operating correctly.This check was performed on 07-aug-2019 and passed the reject verification criteria.A short count carton cannot be confirmed by the site once the carton has been opened.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.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 first complaint for the sub class product container under-filled/short count 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 received at the site on 11feb2020; return sample evaluation: 1 wrap: no obvious defect 1 pouch: (l) cn6723 08/09 exp 2022-07 16:05 wrap pouch opened by consumer 1 carton: (l) cn6723 08/09 exp 2022-07 16:07 carton opened by consumer.Follow-up (06feb2020): new information received from a product quality complaint group included: investigation results.Follow-up (13feb2020): new information from the contactable consumer includes: events skin burning sensation and device issue onset date updated from 27jan2020 to 03jan2020, no treatment or hospitalization were involved, event intentional device misuse onset date added as jan2019, thermacare heatwrap start date and additional indication for use provided.Follow-up attempts are completed.No further information is expected.Follow-up (25mar2020): new information received from product quality complaints included severity rating assessment.Follow-up attempts are completed.No further information is expected.Follow-up (29jul2020): this is a follow up report received from the product quality complaint group includes investigational results for complaint sub-class: product container under-filled/short count and event "use thermacare lower back & hip for issue with sciatic in right leg" added.No follow-up attempts are needed.No further information expected.Follow-up (16oct2020): new information received from the product quality complaint group includes updated trend information for complaint sub-class: wrap/patch/pad too hot.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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The severity of harm was s3.Summary of investigation: batch cn6723 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "got too hot ".The cause of the consumer stating the wrap was too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.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 first complaint for the sub class wrap/patch/pad too hot for this batch.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi customizable search for the subclasses of wrap/patch/pad too hot for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of wrap/patch/pad too hot for lbh product, refer to attachment wrap patch pad too hot lbh 29jan2017 to 29jan2020.This investigation was reopened to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from sop-#, complaint trending guidelines, effective dates 19nov2019 and 24feb2020.A notification of nonconformance was opened pr-#.This deviation will not change the conclusion of the investigation.Site sample status was received at the site on 11feb2020; return sample evaluation: 1 wrap: no obvious defect 1 pouch: (l) cn6723 09aug exp jul2022 16:05 wrap pouch opened by consumer 1 carton: (l) cn6723 09aug exp jul2022 16:07 carton opened by consumer.Summary of investigation: batch cn6723 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 evaluation of the return sample does not confirm the complaint for short count.At the beginning of the production run for the batch, form -53504, b line reject verifications form, effective date: 06-may-2019 was completed to verify the check-weigher was operating correctly.This check was performed on 07-aug-2019 and passed the reject verification criteria.A short count carton cannot be confirmed by the site once the carton has been opened.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.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 first complaint for the sub class product container under-filled/short count 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 received at the site on 11feb2020; return sample evaluation: 1 wrap: no obvious defect 1 pouch: (l) cn6723 08/09 exp 2022-07 16:05 wrap pouch opened by consumer 1 carton: (l) cn6723 08/09 exp 2022-07 16:07 carton opened by consumer.
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Manufacturer Narrative
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The severity of harm was s3.Summary of investigation: batch cn6723 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "got too hot ".The cause of the consumer stating the wrap was too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.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 first complaint for the sub class wrap/patch/pad too hot for this batch.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi customizable search for the subclasses of wrap/patch/pad too hot for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of wrap/patch/pad too hot for lbh product, refer to attachment wrap patch pad too hot lbh 29jan2017 to 29jan2020.This investigation was reopened to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from sop-#, complaint trending guidelines, effective dates 19nov2019 and 24feb2020.A notification of nonconformance was opened pr-#.This deviation will not change the conclusion of the investigation.Site sample status was received at the site on 11feb2020; return sample evaluation: 1 wrap: no obvious defect 1 pouch: (l) cn6723 09aug exp jul2022 16:05 wrap pouch opened by consumer 1 carton: (l) cn6723 09aug exp jul2022 16:07 carton opened by consumer.Summary of investigation: batch cn6723 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 evaluation of the return sample does not confirm the complaint for short count.At the beginning of the production run for the batch, form -53504, b line reject verifications form, effective date: 06-may-2019 was completed to verify the check-weigher was operating correctly.This check was performed on 07-aug-2019 and passed the reject verification criteria.A short count carton cannot be confirmed by the site once the carton has been opened.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.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 first complaint for the sub class product container under-filled/short count 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 received at the site on 11feb2020; return sample evaluation: 1 wrap: no obvious defect 1 pouch: (l) cn6723 08/09 exp 2022-07 16:05 wrap pouch opened by consumer 1 carton: (l) cn6723 08/09 exp 2022-07 16:07 carton opened by consumer.
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Event Description
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Event verbatim [preferred term] now he uses the wrap directly on his skin/kept on back throughout the night until awakening in the morning [intentional device misuse], burning of skin [skin burning sensation], heatwrap got too hot when applied [device issue], use thermacare lower back & hip for issue with sciatic in right leg [device use issue], , narrative: this is a spontaneous report from a contactable consumer reporting for himself.This 82-year-old male consumer started to use thermacare heatwrap (thermacare lower back & hip) (device lot number cn6723, expiration date jul2022, udi number# 305733010037) from jan2019 for issue with back, sciatic in right leg, spinal stenosis thoracic region.Relevant medical history was none.Relevant concomitant medications included general vitamins, in the morning and after dinner, well before he retires for the night.Consumer also reported he used a wrap alternately with salonpas.He applied heat wrap every night upon retiring and kept on back throughout the night until awakening in the morning since jan2019.He had done this for over a year with no similar burning.Consumer reported now he used the wrap directly on his skin, he has always done this with no problems.Consumer reported he used one wrap to his skin as needed.Consumer reported he had a 2 wraps box and he used one heatwrap in the box with success.He stated that the second heatwrap got too hot when applied on 03jan2020, so he removed it immediately to avoid being burned, as soon as he experienced the burning of his skin.Consumer had completely recovered at the time of this report and there was no damage, no admission to hospital involved and no treatment received: the wrap just got too hot.Consumer removed wrap and saved it with the pouch and the box, however he did not save and discarded the box.He was calling to ask for a refund because it is the first time he ever had any burning.He did attend an ortho doctor, the one who recommended him the product.3-4 weeks ago, he at that point, received only one wrap in a box when he purchased it.A sample of the product was available.There was no action taken with thermacare heatwraps, the product was ongoing.The outcome of the events "heatwrap got too hot when applied" "burning of skin" was resolved in jan2020.The outcome of the other events was unknown.According to product quality complaint group for complaint sub-class: wrap/patch/pad too hot: the severity of harm was s3.Summary of investigation: batch cn6723 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "got too hot ".The cause of the consumer stating the wrap was too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.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 first complaint for the sub class wrap/patch/pad too hot for this batch.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi customizable search for the subclasses of wrap/patch/pad too hot for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of wrap/patch/pad too hot for lbh product, refer to attachment wrap patch pad too hot lbh 29jan2017 to 29jan2020.This investigation was reopened to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from sop-#, complaint trending guidelines, effective dates 19nov2019 and 24feb2020.A notification of nonconformance was opened pr-#.This deviation will not change the conclusion of the investigation.Site sample status was received at the site on 11feb2020; return sample evaluation: 1 wrap: no obvious defect 1 pouch: (l) cn6723 09aug exp jul2022 16:05 wrap pouch opened by consumer 1 carton: (l) cn6723 09aug exp jul2022 16:07 carton opened by consumer.Additional investigational results from the product quality complaint for complaint sub-class product container under-filled/short count on 29jul2020: summary of investigation: batch cn6723 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 evaluation of the return sample does not confirm the complaint for short count.At the beginning of the production run for the batch, form -53504, b line reject verifications form, effective date: 06-may-2019 was completed to verify the check-weigher was operating correctly.This check was performed on 07-aug-2019 and passed the reject verification criteria.A short count carton cannot be confirmed by the site once the carton has been opened.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.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 first complaint for the sub class product container under-filled/short count 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 received at the site on 11feb2020; return sample evaluation: 1 wrap: no obvious defect 1 pouch: (l) cn6723 08/09 exp 2022-07 16:05 wrap pouch opened by consumer 1 carton: (l) cn6723 08/09 exp 2022-07 16:07 carton opened by consumer.Follow-up (06feb2020): new information received from a product quality complaint group included: investigation results.Follow-up (13feb2020): new information from the contactable consumer includes: events skin burning sensation and device issue onset date updated from 27jan2020 to 03jan2020, no treatment or hospitalization were involved, event intentional device misuse onset date added as jan2019, thermacare heatwrap start date and additional indication for use provided.Follow-up attempts are completed.No further information is expected.Follow-up (25mar2020): new information received from product quality complaints included severity rating assessment.Follow-up attempts are completed.No further information is expected.Follow-up (29jul2020): this is a follow up report received from the product quality complaint group includes investigational results for complaint sub-class: product container under-filled/short count and event "use thermacare lower back & hip for issue with sciatic in right leg" added.No follow-up attempts are needed.No further information expected.Follow-up (16oct2020): new information received from the product quality complaint group includes updated trend information for complaint sub-class: wrap/patch/pad too hot.Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: evaluation code method - historical data analysis was added.
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Search Alerts/Recalls
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