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| Lot Number T73713; T48946 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
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Event Type
Injury
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Event Description
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2 euro sized burn right on the back [thermal burn].Case narrative: this is a spontaneous report from a contactable pharmacist.A female patient of an unknown age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number lot number 48946) on an unknown date for an unknown indication.Relevant medical history and concomitant medications were not provided.The pharmacist informed that the patient went to the pharmacy on (b)(6) 2020 stating that she used the product and then she got a 2 euro sized burn right on the back.The patient not only wanted a reimbursement of the purchase price or even a replacement pack, but also compensation.The patient was under medical treatment.The pharmacist asked for call-back for reimbursement and the following medical inquiry.The pharmacist saw a video about the recall of thermacare heatwrap batches due to damaged heat cells.She wanted to know whether it was poisonous for the patient if particles from the damaged heat cells got into the subcutaneous fatty tissue.She wanted to have this question answered as soon as possible, since in her opinion this could have an important impact on the medical treatment of the patient.The action taken with thermacare heatwrap in response to the event and the clinical outcome of the event were unknown at the time of the report.Additional information has been requested and will be provided as it becomes available.Comment: based on the information provided, the event "2 euro sized burn right on the back" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] 2 euro sized burn right on the back [thermal burn].Case narrative:this is a spontaneous report from a contactable pharmacist.A female patient of an unknown age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number 48946 and t73713 and expiry date 31aug2020).On an unknown date for an unknown indication.Relevant medical history and concomitant medications were none.The pharmacist informed that the patient went to the pharmacy on (b)(6) 2020 stating that she used the product and then she got a 2 euro sized burn right on the back.Thermacare with lot number t73713 and expiry date 31aug2020 has been applied once and resulted in burn injury after a few hours.The wound has been cared for by the physician, ointment for burns has been applied.No hospital admission nor surgery were required.It was unknown if permanent damage such as scars will remain.Thermacare has been used before and tolerated well.The patient not only wanted a reimbursement of the purchase price or even a replacement pack, but also compensation.The pharmacist asked for call-back for reimbursement and the following medical inquiry.The pharmacist saw a video about the recall of thermacare heatwrap batches due to damaged heat cells.She wanted to know whether it was poisonous for the patient if particles from the damaged heat cells got into the subcutaneous fatty tissue.She wanted to have this question answered as soon as possible, since in her opinion this could have an important impact on the medical treatment of the patient.The action taken with thermacare heatwrap in response to the event and the clinical outcome of the event were unknown at the time of the report.Additional information has been requested and will be provided as it becomes available.Follow-up (16mar2020): new information from the contactable pharmacist includes patient data (initials, weight and height), information about no medical history and concomitant medications, additional lot number (t73713) and expiration date of thermacare which caused the event, treatment of the event and information the thermacare was used in the past without side effect., comment: based on the information provided, the event "2 euro sized burn right on the back" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and event cannot be ruled out.
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Manufacturer Narrative
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A full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, patient experienced two euro size burn.Review of complaint description concludes there is a device malfunction.The root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "2 euro sized burn right on the back".The cause of the consumer developing "2 euro sized burn right on the back" is inconclusive.After a review of the batch thermal records, thermal results all met product release criteria.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.Reasonably suggest device malfunction: yes.Severity of harm: s3.Site sample status: not received.
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Event Description
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Event verbatim [preferred term].2 euro sized burn right on the back [thermal burn].Narrative: this is a spontaneous report from a contactable pharmacist.A female patient of an unknown age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number 48946 and t73713 and expiry date 31aug2020) on an unknown date for an unknown indication.Relevant medical history and concomitant medications were none.Thermacare heatwrap had been used before and tolerated well.The pharmacist informed that the patient went to the pharmacy on (b)(6) 2020 stating that she used the product and then she got a 2 euro sized burn right on the back.Thermacare with lot number t73713 and expiry date 31aug2020 has been applied once and resulted in burn injury after a few hours.The wound has been cared for by the physician, ointment for burns has been applied.No hospital admission nor surgery were required.It was unknown if permanent damage such as scars will remain.The patient not only wanted a reimbursement of the purchase price or even a replacement pack, but also compensation.The pharmacist asked for call-back for reimbursement and the following medical inquiry.The pharmacist saw a video about the recall of thermacare heatwrap batches due to damaged heat cells.She wanted to know whether it was poisonous for the patient if particles from the damaged heat cells got into the subcutaneous fatty tissue.She wanted to have this question answered as soon as possible, since in her opinion this could have an important impact on the medical treatment of the patient.The action taken with thermacare heatwrap in response to the event and the clinical outcome of the event were unknown at the time of the report.Per the quality group: a full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, patient experienced two euro size burn.Review of complaint description concludes there is a device malfunction.The root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "2 euro sized burn right on the back".The cause of the consumer developing "2 euro sized burn right on the back" is inconclusive.After a review of the batch thermal records, thermal results all met product release criteria.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.Reasonably suggest device malfunction: yes.Severity of harm: s3.Site sample status: not received.Follow-up (16mar2020): new information from the contactable pharmacist includes patient data (initials, weight and height), information about no medical history and concomitant medications, additional lot number (t73713) and expiration date of thermacare which caused the event, treatment of the event and information the thermacare was used in the past without side effect.Follow-up (24apr2020): new information received from product complaints includes: investigation assessment and summary.Comment: based on the information provided, the event "2 euro sized burn right on the back" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and event cannot be ruled out.
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Manufacturer Narrative
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A full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, patient experienced two euro size burn.Review of complaint description concludes there is a device malfunction.The root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "2 euro sized burn right on the back".The cause of the consumer developing "2 euro sized burn right on the back" is inconclusive.After a review of the batch thermal records, thermal results all met product release criteria.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.Reasonably suggest device malfunction: yes.Severity of harm: s3.Site sample status: not received.
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Event Description
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Event verbatim [preferred term] 2 euro sized burn right on the back [thermal burn], , narrative: this is a spontaneous report from a contactable pharmacist.A female patient of an unknown age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number t48946; device lot number t73713 and expiry date 31aug2020) on an unknown date for an unknown indication.Relevant medical history and concomitant medications were none.Thermacare heatwrap had been used before and tolerated well.The pharmacist informed that the patient went to the pharmacy on (b)(6) 2020 stating that she used the product and then she got a 2 euro sized burn right on the back.Thermacare with lot number t73713 and expiry date 31aug2020 has been applied once and resulted in burn injury after a few hours.The wound has been cared for by the physician, ointment for burns has been applied.No hospital admission nor surgery were required.It was unknown if permanent damage such as scars will remain.The patient not only wanted a reimbursement of the purchase price or even a replacement pack, but also compensation.The pharmacist asked for call-back for reimbursement and the following medical inquiry.The pharmacist saw a video about the recall of thermacare heatwrap batches due to damaged heat cells.She wanted to know whether it was poisonous for the patient if particles from the damaged heat cells got into the subcutaneous fatty tissue.She wanted to have this question answered as soon as possible, since in her opinion this could have an important impact on the medical treatment of the patient.The action taken with thermacare heatwrap in response to the event and the clinical outcome of the event were unknown at the time of the report.Per the quality group: a full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, patient experienced two euro size burn.Review of complaint description concludes there is a device malfunction.The root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "2 euro sized burn right on the back".The cause of the consumer developing "2 euro sized burn right on the back" is inconclusive.After a review of the batch thermal records, thermal results all met product release criteria.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.Reasonably suggest device malfunction: yes.Severity of harm: s3.Site sample status: not received.Follow-up ((b)(6) 2020): new information from the contactable pharmacist includes patient data (initials, weight and height), information about no medical history and concomitant medications, additional lot number (t73713) and expiration date of thermacare which caused the event, treatment of the event and information the thermacare was used in the past without side effect.Follow-up ((b)(6) 2020): new information received from product complaints includes: investigation assessment and summary.Follow-up ((b)(6) 2020): new information received from the same contactable pharmacist included: updated lot number not involved with the event (t48946).Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to a20mend previously reported information: the awareness date of last follow-up was (b)(6) 2020 (not (b)(6) 2029 as previously reported in the narrative).Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event "2 euro sized burn right on the back" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and event cannot be ruled out.
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Manufacturer Narrative
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Severity of harm was s3.Site sample status was not received.Batch t73713 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated no quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "2 euro sized burn right on the back" the cause of the consumer developing "2 euro sized burn right on the back¿ is inconclusive.After a review of the batch thermal records, thermal results all met product release criteria.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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the third complaint for the subclass adverse event/serious/unknown received at the albany site, requiring evaluation for this batch.The previous complaints were not confirmed to have manufacturing root cause related to the subclass.Per sop-105746, complaint trending guideline, effective 24-feb-2020, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to trending chart attachment adverse event serious unknown t73713.On this basis, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event/serious/unknown.Refer to the 36-month trend chart attachment refer to attachment flexible use xl ae serious unknown 02-21-2017 to 02-21-2020.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 pr-5283155, action item pr-5283193.
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Event Description
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Event verbatim [preferred term] 2 euro sized burn right on the back [thermal burn], , narrative: this is a spontaneous report from a contactable pharmacist.A female patient of an unknown age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number t48946; device lot number t73713 and expiry date 31aug2020) on an unknown date for an unknown indication.Relevant medical history and concomitant medications were none.Thermacare heatwrap had been used before and tolerated well.The pharmacist informed that the patient went to the pharmacy on 15feb2020 stating that she used the product and then she got a 2 euro sized burn right on the back.Thermacare with lot number t73713 and expiry date 31aug2020 has been applied once and resulted in burn injury after a few hours.The wound has been cared for by the physician, ointment for burns has been applied.No hospital admission nor surgery were required.It was unknown if permanent damage such as scars will remain.The pharmacist saw a video about the recall of thermacare heatwrap batches due to damaged heat cells.She wanted to know whether it was poisonous for the patient if particles from the damaged heat cells got into the subcutaneous fatty tissue.She wanted to have this question answered as soon as possible, since in her opinion this could have an important impact on the medical treatment of the patient.The action taken with thermacare heatwrap in response to the event and the clinical outcome of the event were unknown.According to the product quality complaint group: severity of harm was s3.Site sample status was not received.Batch t73713 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated no quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "2 euro sized burn right on the back" the cause of the consumer developing "2 euro sized burn right on the back" is inconclusive.After a review of the batch thermal records, thermal results all met product release criteria.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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the third complaint for the subclass adverse event/serious/unknown received at the albany site, requiring evaluation for this batch.The previous complaints were not confirmed to have manufacturing root cause related to the subclass.Per sop-105746, complaint trending guideline, effective 24-feb-2020, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to trending chart attachment adverse event serious unknown t73713.On this basis, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event/serious/unknown.Refer to the 36-month trend chart attachment refer to attachment flexible use xl ae serious unknown 02-21-2017 to 02-21-2020.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 pr-5283155, action item pr-5283193.Follow-up (16mar2020): new information from the contactable pharmacist includes patient data (initials, weight and height), information about no medical history and concomitant medications, additional lot number (t73713) and expiration date of thermacare which caused the event, treatment of the event and information the thermacare was used in the past without side effect.Follow-up (24apr2020): new information received from product complaints includes: investigation assessment and summary.Follow-up (30apr2020): new information received from the same contactable pharmacist included: updated lot number not involved with the event (t48946).Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: the awareness date of last follow-up was 30apr2020 (not 30apr2029 as previously reported in the narrative).Follow-up attempts are completed.No further information is expected.Follow-up (12oct2020): new information received from the product quality complaint group includes updated trend information.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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Event Description
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Event verbatim [preferred term] 2 euro sized burn right on the back [thermal burn], , narrative: this is a spontaneous report from a contactable pharmacist.A female patient of an unknown age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number t48946; device lot number t73713 and expiry date 31aug2020) on an unknown date for an unknown indication.Relevant medical history and concomitant medications were none.Thermacare heatwrap had been used before and tolerated well.The pharmacist informed that the patient went to the pharmacy on 15feb2020 stating that she used the product and then she got a 2 euro sized burn right on the back.Thermacare with lot number t73713 and expiry date 31aug2020 has been applied once and resulted in burn injury after a few hours.The wound has been cared for by the physician, ointment for burns has been applied.No hospital admission nor surgery were required.It was unknown if permanent damage such as scars will remain.The pharmacist saw a video about the recall of thermacare heatwrap batches due to damaged heat cells.She wanted to know whether it was poisonous for the patient if particles from the damaged heat cells got into the subcutaneous fatty tissue.She wanted to have this question answered as soon as possible, since in her opinion this could have an important impact on the medical treatment of the patient.The action taken with thermacare heatwrap in response to the event and the clinical outcome of the event were unknown.According to the product quality complaint group: severity of harm was s3.Site sample status was not received.Batch t73713 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated no quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "2 euro sized burn right on the back" the cause of the consumer developing "2 euro sized burn right on the back" is inconclusive.After a review of the batch thermal records, thermal results all met product release criteria.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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the third complaint for the subclass adverse event/serious/unknown received at the albany site, requiring evaluation for this batch.The previous complaints were not confirmed to have manufacturing root cause related to the subclass.Per sop-105746, complaint trending guideline, effective 24-feb-2020, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to trending chart attachment adverse event serious unknown t73713.On this basis, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event/serious/unknown.Refer to the 36-month trend chart attachment refer to attachment flexible use xl ae serious unknown 02-21-2017 to 02-21-2020.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 (16mar2020): new information from the contactable pharmacist includes patient data (initials, weight and height), information about no medical history and concomitant medications, additional lot number (t73713) and expiration date of thermacare which caused the event, treatment of the event and information the thermacare was used in the past without side effect.Follow-up (24apr2020): new information received from product complaints includes: investigation assessment and summary.Follow-up (30apr2020): new information received from the same contactable pharmacist included: updated lot number not involved with the event (t48946).Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: the awareness date of last follow-up was 30apr2020 (not 30apr2029 as previously reported in the narrative).Follow-up attempts are completed.No further information is expected.Follow-up (12oct2020): new information received from the product quality complaint group includes updated trend information.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Severity of harm was s3.Site sample status was not received.Batch t73713 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated no quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "2 euro sized burn right on the back" the cause of the consumer developing "2 euro sized burn right on the back¿ is inconclusive.After a review of the batch thermal records, thermal results all met product release criteria.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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the third complaint for the subclass adverse event/serious/unknown received at the albany site, requiring evaluation for this batch.The previous complaints were not confirmed to have manufacturing root cause related to the subclass.Per sop-105746, complaint trending guideline, effective 24-feb-2020, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to trending chart attachment adverse event serious unknown t73713.On this basis, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event/serious/unknown.Refer to the 36-month trend chart attachment refer to attachment flexible use xl ae serious unknown 02-21-2017 to 02-21-2020.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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