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| Lot Number AP2395 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Tissue Damage (2104); 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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Burns [thermal burn], the skin has come off in those spots [skin exfoliation].Case narrative: this is a spontaneous report from a contactable consumer.This consumer reported similar events for two patients.This is the second of 2 reports, reporting for the consumer's mother.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), from an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The consumer reported, in the last month (in 2019), the patient got burns by using thermacare.The burns were pretty bad, the skin had come off in those spots.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "burns were pretty bad, the skin had come off in those spots" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] burns [thermal burn] , the skin has come off in those spots [skin exfoliation] ,.Case narrative:this is a spontaneous report from a contactable consumer.This consumer reported similar events for two patients.This is the second of 2 reports, reporting for the consumer's mother.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number: ap2395, expiration date: jan2022, from an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The consumer reported, in the last month (in 2019), the patient got burns by using thermacare.The burns were pretty bad, the skin had come off in those spots.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.According to product quality complaint group: subclass: adverse event safety request for investigation; sample status: photos attached; investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Process related? no.Complaint confirmed? no.Design related? no.Notify safety? no.Follow-up (13jun2019): new information received from product quality complaint group includes investigation results and product data (lot number and expiration date).Company clinical evaluation comment based on the information provided, the events of "burns were pretty bad, the skin had come off in those spots" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "burns were pretty bad, the skin had come off in those spots" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Subclass: adverse event safety request for investigation; sample status: photos attached; investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Process related? no.Complaint confirmed? no.Design related? no.Notify safety? no.
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Event Description
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Event verbatim [preferred term] burns [thermal burn] , the skin has come off in those spots [skin exfoliation] ,.Case narrative:this is a spontaneous report from a contactable consumer.This consumer reported similar events for two patients.This is the second of 2 reports, reporting for the consumer's mother.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number: ap2395, expiration date: jan2022, from an unspecified date at an unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The consumer reported, in the last month (in 2019), the patient got burns by using thermacare.The burns were pretty bad, the skin had come off in those spots.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.According to product quality complaint group: subclass: adverse event safety request for investigation; sample status: investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Process related? no.Complaint confirmed? no.Design related? no.Notify safety? no.Upon follow-up, product quality complaints provided severity rating as s3 (injury, which could result in the need for medical treatment and hospitalization.) follow-up (13jun2019): new information received from product quality complaint group includes investigation results and product data (lot number and expiration date).Follow-up (13aug2019): new information from product quality complaints includes: severity rating (s3).Amendment: this report is being submitted to amend previously reported information: company clinical evaluation comment added to the narrative.Company clinical evaluation comment: based on the information provided, the events of "burns were pretty bad, the skin had come off in those spots" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.Follow-up (02sep2019): follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events of "burns were pretty bad, the skin had come off in those spots" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Subclass: adverse event safety request for investigation; investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Process related? no.Complaint confirmed? no.Design related? no.Notify safety? no.
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Event Description
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Event verbatim [preferred term] burns [thermal burn] , the skin has come off in those spots [skin exfoliation] ,.Case narrative:this is a spontaneous report from a contactable consumer.This consumer reported similar events for two patients.This is the second of 2 reports, reporting for the consumer's mother.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number: ap2395, expiration date: jan2022, from an unspecified date at an unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The consumer reported, in the last month (in 2019), the patient got burns by using thermacare.The burns were pretty bad, the skin had come off in those spots.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.According to product quality complaint group: subclass: adverse event safety request for investigation; sample status: photos attached; investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Process related? no.Complaint confirmed? no.Design related? no.Notify safety? no.Upon follow-up, product quality complaints provided severity rating as s3 (injury, which could result in the need for medical treatment and hospitalization.) follow-up (13jun2019): new information received from product quality complaint group includes investigation results and product data (lot number and expiration date).Follow-up (13aug2019): new information from product quality complaints includes: severity rating (s3)., comment: based on the information provided, the events of "burns were pretty bad, the skin had come off in those spots" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Subclass: adverse event safety request for investigation; sample status: photos attached; investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Process related? no.Complaint confirmed? no.Design related? no.Notify safety? no.
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Event Description
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Event verbatim [preferred term] burns [thermal burn] , the skin has come off in those spots [skin exfoliation] ,.Case narrative:this is a spontaneous report from a contactable consumer.This consumer reported similar events for two patients.This is the second of 2 reports, reporting for the consumer's mother.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number: ap2395, expiration date: jan2022, from an unspecified date at an unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The consumer reported, in the last month (in 2019), the patient got burns by using thermacare.The burns were pretty bad, the skin had come off in those spots.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.According to product quality complaint group: subclass: adverse event safety request for investigation; sample status: photos attached; investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Process related? no.Complaint confirmed? no.Design related? no.Notify safety? no.Upon follow-up, product quality complaints provided severity rating as s3 (injury, which could result in the need for medical treatment and hospitalization.) follow-up (13jun2019): new information received from product quality complaint group includes investigation results and product data (lot number and expiration date).Follow-up (13aug2019): new information from product quality complaints includes: severity rating (s3).Amendment: this report is being submitted to amend previously reported information: company clinical evaluation comment added to the narrative.Follow-up (02sep2019): follow-up attempts are completed.No further information is expected.Amendment: this report is being submitted to amend previously reported information: device malfunction updated as no.Company clinical evaluation comment: based on the information provided, the events of "burns were pretty bad, the skin had come off in those spots" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "burns were pretty bad, the skin had come off in those spots" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Subclass: adverse event safety request for investigation; sample status: photos attached; investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Process related? no.Complaint confirmed? no.Design related? no.Notify safety? no.
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Manufacturer Narrative
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Subclass: adverse event safety request for investigation; sample status: photos attached; investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Process related? no.Complaint confirmed? no.Design related? no.Notify safety? no.There were no photos available.Site sample status was not received.The expiration date associated with lot ap2395 according to product quality complaints is 31dec2019.There was reasonable suggestion of device malfunction.Batch ap2395 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety/serious/unknown received at the (site name) site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaints intake, triage and investigation (citi) customizable search was performed.Review of the batch device history record for this batch concludes all release requirements were met.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 criteri.
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Event Description
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Event verbatim [preferred term] burns [thermal burn] , the skin has come off in those spots [skin exfoliation] ,.Case narrative:this is a spontaneous report from a contactable consumer.This consumer reported similar events for two patients.This is the second of 2 reports, reporting for the consumer's mother.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number: ap2395, expiration date: jan2022 according to the reporter and 31dec2019 according to product quality complaints), from an unspecified date at an unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The consumer reported, in the last month (in 2019), the patient got burns by using thermacare.The burns were pretty bad, the skin had come off in those spots.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.According to product quality complaint group: subclass: adverse event safety request for investigation; sample status: photos attached; investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Process related? no.Complaint confirmed? no.Design related? no.Notify safety? no.Upon follow-up, product quality complaints provided severity rating as s3 (injury, which could result in the need for medical treatment and hospitalization.) product quality complaints provided the following additional investigation information: there were no photos available.Site sample status was not received.The expiration date associated with lot ap2395 according to product quality complaints is 31dec2019.There was reasonable suggestion of device malfunction.Batch ap2395 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety/serious/unknown received at the (site name) site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaints intake, triage and investigation (citi) customizable search was performed.Review of the batch device history record for this batch concludes all release requirements were met.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.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c to 41.6°c) per spec-25354; effective date: 27mar2018.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.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 caused a "burn." the cause of the wrap causing a burn 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 (13jun2019): new information received from product quality complaint group includes investigation results and product data (lot number and expiration date).Follow-up (13aug2019): new information from product quality complaints includes: severity rating (s3).Amendment: this report is being submitted to amend previously reported information: company clinical evaluation comment added to the narrative.Follow-up (02sep2019): follow-up attempts are completed.No further information is expected.Amendment: this report is being submitted to amend previously reported information: device malfunction updated as no.Follow up (30aug2019): new information from product quality complaints includes: investigation results and expiry.Follow-up attempts are completed.No further information is expected company clinical evaluation comment: based on the information provided, the events of "burns were pretty bad, the skin had come off in those spots" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "burns were pretty bad, the skin had come off in those spots" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Search Alerts/Recalls
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