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| Lot Number AR5204 |
| Device Problems
Overheating of Device (1437); Excessive Heating (4030)
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| Patient Problems
Erythema (1840); Skin Irritation (2076)
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Event Type
Injury
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Event Description
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Skin irritation, redness, as it was too hot [erythema] , redness, as it was too hot [device issue] , she could not tolerate the product [device intolerance] ,.Case narrative:this is a spontaneous report from a contactable pharmacist via medical information team.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwrap), device lot number ar5204, expiration date mar2022, from an unspecified date used for 8 hours, for back pain.The patient's medical history and concomitant medications were not reported.The patient experienced skin irritation on an unspecified date.The patient experienced redness, as it was too hot on an unspecified date.The patient experienced she could not tolerate the product on an unspecified date.The action taken with thermacare heatwrap was permanently withdrawn.The outcome of the event redness was recovered and for all other events was unknown.Additional information has been requested and will be provided as it becomes available., comment: based on the available information, the complaints of "skin irritation, redness, as it was too hot" are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The complaint of "could not tolerate the product" is considered non-serious.A causal relationship between the device and the above complaints cannot be ruled out.
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Manufacturer Narrative
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Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "heat wraps were too hot." the cause of the consumer reporting "heat wraps were too hot" is inconclusive.The review of records does not provide evidence to support the 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.
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Event Description
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Event verbatim [preferred term] skin irritation [skin irritation] , redness, as it was too hot [erythema] , redness, as it was too hot [device issue] , she could not tolerate the product [device intolerance].Case narrative:this is a spontaneous report from a contactable pharmacist via medical information team.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwrap), device lot number ar5204, expiration date mar2022, from an unspecified date used for 8 hours, for back pain.The patient's medical history and concomitant medications were not reported.The patient experienced skin irritation on an unspecified date.The patient experienced redness, as it was too hot on an unspecified date.The patient experienced she could not tolerate the product on an unspecified date.The action taken with thermacare heatwrap was permanently withdrawn.The outcome of the event redness was recovered and for all other events was unknown.Product investigation results were as follows: 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 "heat wraps were too hot." the cause of the consumer reporting "heat wraps were too hot" is inconclusive.The review of records does not provide evidence to support the 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.Follow-up (18mar2020): new information received from product quality complaint group includes: investigation summary.Follow-up attempts are completed.No further information is expected., comment: based on the available information, the complaints of "skin irritation, redness, as it was too hot" are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The complaint of "could not tolerate the product" is considered non-serious.A causal relationship between the device and the above complaints 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 remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "heat wraps were too hot." the cause of the consumer reporting "heat wraps were too hot" is inconclusive.The review of records does not provide evidence to support the 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.Severity of harm was selected as s3.
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Event Description
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Event verbatim [preferred term] skin irritation [skin irritation] , redness, as it was too hot [erythema] , redness, as it was too hot [device issue] , she could not tolerate the product [device intolerance] ,.Case narrative:this is a spontaneous report from a contactable pharmacist via medical information team.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwrap), device lot number ar5204, expiration date mar2022, from an unspecified date used for 8 hours, for back pain.The patient's medical history and concomitant medications were not reported.The patient experienced skin irritation on an unspecified date.The patient experienced redness, as it was too hot on an unspecified date.The patient experienced she could not tolerate the product on an unspecified date.The action taken with thermacare heatwrap was permanently withdrawn.The outcome of the event redness was recovered and for all other events was unknown.Product investigation results were as follows: 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 "heat wraps were too hot." the cause of the consumer reporting "heat wraps were too hot" is inconclusive.The review of records does not provide evidence to support the 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.Severity of harm was selected as s3.Follow-up attempts are completed.No further information is expected.Follow-up (18mar2020): new information received from product quality complaint group includes: investigation summary.Follow-up (25mar2020): new information received from product quality compliant group includes severity of harm (s3)., comment: based on the available information, the complaints of "skin irritation, redness, as it was too hot" are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The complaint of "could not tolerate the product" is considered non-serious.A causal relationship between the device and the above complaints 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 remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "heat wraps were too hot." the cause of the consumer reporting "heat wraps were too hot" is inconclusive.The review of records does not provide evidence to support the 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.Severity of harm was selected as s3.Summary of investigation: batch ar5204 is the only batch within the scope of this investigation.Theremacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.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 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.Exped trend actions taken: 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 (b)(6) 2017 to (b)(6) 2020.There was deviation from (b)(4), 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).Additional information received from product quality group includes: site sample has not been received.Summary of investigation:batch ar5204 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.Lot trend actions taken: a trend does not exist for this lot.Lot trend assessment.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.The previous investigation was not confirmed to have a manufacturing root cause related to the complaint.Per (b)(4), complaint trending guidelines,effective (b)(6) 2020, a visual examination was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to attachment adverse event serious unknown ar5204.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assessment & rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi customizable search for the subclasses of adverse event/serious/unknown for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown for lbh product, refer to attachment lbh adverse event serious unknown (b)(6) 2017 to (b)(6)2020.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 experiencing "redness, as it was too hot." the cause of the consumer stating she experienced "redness, as it 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.
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Event Description
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Event verbatim [preferred term].Skin irritation [skin irritation], redness, as it was too hot [erythema], redness, as it was too hot [device issue], she could not tolerate the product [device intolerance].Narrative: this is a spontaneous report from two contactable pharmacists via medical information team.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip ), device lot number ar5204, expiration date mar2022, from an unspecified date used for 8 hours, for back pain.The patient's medical history and concomitant medications were not reported.The patient experienced skin irritation on an unspecified date.The patient experienced redness, as it was too hot on an unspecified date.The patient experienced she could not tolerate the product on an unspecified date.The action taken with thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the event "redness, as it was too hot" was recovered on an unspecified date and for all other events was unknown.Product investigation results were as follows: 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 "heat wraps were too hot." the cause of the consumer reporting "heat wraps were too hot" is inconclusive.The review of records does not provide evidence to support the 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.Severity of harm was selected as s3.Summary of investigation: batch ar5204 is the only batch within the scope of this investigation.Theremacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.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 received at the (b)(6) site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Exped trend actions taken: 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 (b)(6) 2017 to (b)(6) 2020.There was deviation from (b)(4), 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).Additional information regarding sub class adverse event/serious/unknown received from product quality group includes: site sample has not been received.Summary of investigation: batch ar5204 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.Lot trend actions taken: a trend does not exist for this lot.Lot trend assessment.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event/serious/unknown received at the (b)(6) site requiring an evaluation for this batch.The previous investigation was not confirmed to have a manufacturing root cause related to the complaint.Per (b)(4), complaint trending guidelines, effective (b)(6) 2020, a visual examination was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to attachment adverse event serious unknown ar5204.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assessment.& rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi customizable search for the subclasses of adverse event/serious/unknown for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown for lbh product, refer to attachment lbh adverse event serious unknown (b)(6) 2017 to (b)(6) 2020.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 experiencing "redness, as it was too hot." the cause of the consumer stating she experienced "redness, as it 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.Follow-up attempts are completed.No further information is expected.Follow-up (18mar2020): new information received from product quality complaint group includes: investigation summary.Follow-up (25mar2020): new information received from product quality compliant group includes severity of harm (s3).Follow-up (13oct2020): new information received from product quality complaint group includes: updated trending information.Follow-up (09nov2020): new information received from product quality complaint group includes additional investigation result.This follow-up report is also being submitted to amend previously reported information: update product trade name from thermacare heatwrap to thermacare lower back & hip., comment: based on the available information, the complaints of "skin irritation, redness, as it was too hot" are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The complaint of "could not tolerate the product" is considered non-serious.A causal relationship between the device and the above complaints 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 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] skin irritation [skin irritation], redness, as it was too hot [erythema], redness, as it was too hot [device issue], she could not tolerate the product [device intolerance], narrative: this is a spontaneous report from two contactable pharmacists via medical information team.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwrap), device lot number ar5204, expiration date mar2022, from an unspecified date used for 8 hours, for back pain.The patient's medical history and concomitant medications were not reported.The patient experienced skin irritation on an unspecified date.The patient experienced redness, as it was too hot on an unspecified date.The patient experienced she could not tolerate the product on an unspecified date.The action taken with thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the event "redness, as it was too hot" was recovered on an unspecified date and for all other events was unknown.Product investigation results were as follows: 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 "heat wraps were too hot." the cause of the consumer reporting "heat wraps were too hot" is inconclusive.The review of records does not provide evidence to support the 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.Severity of harm was selected as s3.Summary of investigation: batch ar5204 is the only batch within the scope of this investigation.Theremacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.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 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.Exped trend actions taken: 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 10-mar-2017 to 10-mar-2020.There was deviation from sop-105746, complaint trending guidelines, effective 24-feb-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).Follow-up attempts are completed.No further information is expected.Follow-up (18mar2020): new information received from product quality complaint group includes: investigation summary.Follow-up (25mar2020): new information received from product quality compliant group includes severity of harm (s3).Follow-up (13oct2020): new information received from product quality complaint group includes: updated trending information.Follow-up attempts are completed.No further information is expected., comment: based on the available information, the complaints of "skin irritation, redness, as it was too hot" are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The complaint of "could not tolerate the product" is considered non-serious.A causal relationship between the device and the above complaints 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 remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "heat wraps were too hot." the cause of the consumer reporting "heat wraps were too hot" is inconclusive.The review of records does not provide evidence to support the 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.Severity of harm was selected as s3.Summary of investigation: batch ar5204 is the only batch within the scope of this investigation.Theremacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.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 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.Exped trend actions taken: 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 10-mar-2017 to 10-mar-2020.There was deviation from sop-105746, complaint trending guidelines, effective 24-feb-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).
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Search Alerts/Recalls
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