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| Lot Number AW2091 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Pain (1994); Burn, Thermal (2530); Caustic/Chemical Burns (2549); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
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| Event Date 01/19/2020 |
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Event Type
Injury
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Event Description
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1st and 2nd degree burns across my back from the product [burns first degree], 1st and 2nd degree burns across my back from the product/possible chemical burns/thermal burns/ caused a great deal of pain [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer.This consumer of unknown age and gender started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for severe back pain.Medical history and concomitant medications were not reported.Consumer used the product as a supplemental therapy for severe back pain.As a result consumer received 1st and 2nd degree burns across back from the product causing possible chemical burns/thermal burns.Product was not directly on skin.Now caused a great deal of pain and days off work and a great loss of money and possible disfigurement.Consumer got burned by the product.This needs to be rectified immediately so it didn't happen again.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.Company clinical evaluation comment: based on the information provided, the events "1st and 2nd degree burns across back" are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.Comment: based on the information provided, the events "1st and 2nd degree burns across back" are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.
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Event Description
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Event verbatim [preferred term] 1st and 2nd degree burns across my back from the product [burns first degree] , 1st and 2nd degree burns across my back from the product/possible chemical burns/thermal burns/caused a great deal of pain/2nd burns with blisters to scabs to burn area [burns second degree].Case narrative:this is a spontaneous report from a contactable consumer (patient).A 65-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number aw2091, expiration date feb2022) on (b)(6) 2020 for severe low back pain.Relevant medical history included rheumatoid arthritis (currently under the care of a physician) and she was not pregnant, post-menopausal.She had dark or olive skin, did not have sensitive skin and did not have any abnormal skin conditions.Concomitant medications were none.On (b)(6) 2020, the patient used the product as therapy for severe low back pain.She had never used thermacare heatwrap or other heat products for pain relief before.She used it for 4 hours.As a result, on the same day she experienced 1st and 2nd degree burns across back from the product causing possible chemical burns/thermal burns.It caused a great deal of pain and days off work and a great loss of money and possible disfigurement.She got burned by the product.This needed to be rectified immediately so it didn't happen again.She then specified that she experienced 2nd burns with blisters to scabs to burn area.She checked her skin under the product every 2 hours while wearing it.The product was not directly on skin.She did not engage in exercise while using it.She read the usage instruction before using the product.She was not admitted to hospital and did not receive any treatment in response to the events.She did not consult a healthcare professional for the events.She had remaining product.At the time of the report, she was no longer using the product and was still experiencing the events.Amendment: this follow-up report is being submitted to amend previously reported information: malfunction field ticked yes as this case was also a reportable malfunction mdr.Follow-up (18feb2020): new information from the same contactable consumer included: patient's data, device lot number and expiration date, start date of the product and continuing status (no longer using it), medical history, concomitant medications (none), onset date of the events, details on device use, specification that the patient experienced 2nd burns with blisters to scabs to burn area, information that the patient was not admitted to hospital and did not receive any treatment in response to the events and clinical outcome of the events.Additional information has been requested and will be provided as it becomes available., comment: based on the information provided, the events "1st and 2nd degree burns across back" are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.
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Event Description
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Event verbatim [preferred term] 1st and 2nd degree burns across my back from the product [burns first degree] , 1st and 2nd degree burns across my back from the product/possible chemical burns/thermal burns/ caused a great deal of pain [burns second degree].Case narrative:this is a spontaneous report from a contactable consumer.This consumer of unknown age and gender started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for severe back pain.Medical history and concomitant medications were not reported.Consumer used the product as a supplemental therapy for severe back pain.As a result consumer received 1st and 2nd degree burns across back from the product causing possible chemical burns/thermal burns.Product was not directly on skin.Now caused a great deal of pain and days off work and a great loss of money and possible disfigurement.Consumer got burned by the product.This needs to be rectified immediately so it didn't happen again.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: malfunction field ticked yes as this case was also a reportable malfunction mdr.Company clinical evaluation comment: based on the information provided, the events "1st and 2nd degree burns across back" are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out., comment: based on the information provided, the events "1st and 2nd degree burns across back" are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.
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Event Description
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Event verbatim [preferred term] 1st and 2nd degree burns across my back from the product [burns first degree] , 1st and 2nd degree burns across my back from the product/possible chemical burns/thermal burns/caused a great deal of pain/2nd burns with blisters to scabs to burn area [burns second degree].Case narrative:this is a spontaneous report from a contactable consumer (patient).A 65-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number aw2091, expiration date feb2022) on 19jan2020 for severe low back pain.Relevant medical history included ongoing rheumatoid arthritis (currently under the care of a physician) and she was not pregnant, post-menopausal.She had dark or olive skin, did not have sensitive skin and did not have any abnormal skin conditions.Concomitant medications were none.On 19jan2020, the patient used the product as therapy for severe low back pain.She had never used thermacare heatwrap or other heat products for pain relief before.She used it for 4 hours.As a result, on the same day she experienced 1st and 2nd degree burns across back from the product causing possible chemical burns/thermal burns.It caused a great deal of pain and days off work and a great loss of money and possible disfigurement.She got burned by the product.This needed to be rectified immediately so it didn't happen again.She then specified that she experienced 2nd burns with blisters to scabs to burn area.She checked her skin under the product every 2 hours while wearing it.The product was not directly on skin.She did not engage in exercise while using it.She read the usage instruction before using the product.She was not admitted to hospital and did not receive any treatment in response to the events.She did not consult a healthcare professional for the events.She had remaining product.At the time of the report, she was no longer using the product and was still experiencing the events.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2020.The outcome of the events was not recovered.According to the product quality complaint group: reasonably suggest device malfunction: yes.Severity of harm was provided as s3.Batch aw20915 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.Based on the complaint narrative the preliminary investigation findings suggest burns occurred while used by the customer] the customer sustained an injury of first and second degree burns.The review of the current information suggests there was a product malfunction that contributed to the injury.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 "1st and 2nd degree burns." the cause of the consumer stating the wrap caused "1st and 2nd degree burns" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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 adverse event/serious/unknown.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass adverse event/serious/unknown, adverse event safety request for investigation and adverse event negligible-minor for lbh 8hr products.Site sample status was not received.Amendment: this follow-up report is being submitted to amend previously reported information: malfunction field ticked yes as this case was also a reportable malfunction mdr.Follow-up (18feb2020): new information from the same contactable consumer included: patient's data, device lot number and expiration date, start date of the product and continuing status (no longer using it), medical history, concomitant medications (none), onset date of the events, details on device use, specification that the patient experienced 2nd burns with blisters to scabs to burn area, information that the patient was not admitted to hospital and did not receive any treatment in response to the events and clinical outcome of the events.Follow-up (07mar2020): new information received from the product quality complaint group included investigational results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events "1st and 2nd degree burns across back" are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the 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.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Batch aw20915 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.Based on the complaint narrative the preliminary investigation findings suggest burns occurred while used by the customer] the customer sustained an injury of first and second degree burns.The review of the current information suggests there was a product malfunction that contributed to the injury.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 "1st and 2nd degree burns." the cause of the consumer stating the wrap caused "1st and 2nd degree burns" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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 adverse event/serious/unknown.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclas.
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Event Description
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1st and 2nd degree burns across my back from the product [burns first degree], 1st and 2nd degree burns across my back from the product / possible chemical burns / thermal burns / caused a great deal of pain / 2nd burns with blisters to scabs to burn area [burns second degree].Narrative: this is a spontaneous report from a contactable consumer (patient).A 65-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: aw2091, expiration date: feb2022) on (b)(6) 2020 for severe low back pain.Relevant medical history included ongoing rheumatoid arthritis (currently under the care of a physician) and she was not pregnant, post-menopausal.She had dark or olive skin, did not have sensitive skin and did not have any abnormal skin conditions.Concomitant medications were none.On (b)(6) 2020, the patient used the product as therapy for severe low back pain.She had never used thermacare heatwrap or other heat products for pain relief before.She used it for 4 hours.As a result, on the same day she experienced 1st and 2nd degree burns across back from the product causing possible chemical burns / thermal burns.It caused a great deal of pain and days off work and a great loss of money and possible disfigurement.She got burned by the product.This needed to be rectified immediately so it didn't happen again.She then specified that she experienced 2nd burns with blisters to scabs to burn area.She checked her skin under the product every 2 hours while wearing it.The product was not directly on skin.She did not engage in exercise while using it.She read the usage instruction before using the product.She was not admitted to hospital and did not receive any treatment in response to the events.She did not consult a healthcare professional for the events.She had remaining product.At the time of the report, she was no longer using the product and was still experiencing the events.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on 19jan2020.The outcome of the events was not recovered.According to the product quality complaint group: reasonably suggest device malfunction: yes.Severity of harm was provided as s3.Batch: aw2091 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.Based on the complaint narrative the preliminary investigation findings suggest burns occurred while used by the customer.The customer sustained an injury of first and second degree burns.The review of the current information suggests there was a product malfunction that contributed to the injury.The root cause category is non assignable (complaint not confirmed as a quality defect).The return sample evaluation does not confirm the complaint for the consumer receiving burns.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "1st and 2nd degree burns." the cause of the consumer stating the wrap caused "1st and 2nd degree burns" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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 adverse event/serious/unknown.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass adverse event / serious / unknown, adverse event safety request for investigation and adverse event negligible-minor for lbh 8hr products.Sample was received at the site.Return sample evaluation: one wrap- cells are hard appeared to have brine.Wrap is soiled.Amendment: this follow-up report is being submitted to amend previously reported information: malfunction field ticked yes as this case was also a reportable malfunction mdr.Follow-up (18feb2020): new information from the same contactable consumer included: patient's data, device lot number and expiration date, start date of the product and continuing status (no longer using it), medical history, concomitant medications (none), onset date of the events, details on device use, specification that the patient experienced 2nd burns with blisters to scabs to burn area, information that the patient was not admitted to hospital and did not receive any treatment in response to the events and clinical outcome of the events.Follow-up (07mar2020): new information received from the product quality complaint group included investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (28aug2020): new information received from product quality complaint group included updated investigational results, sample was received at the site.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events "1st and 2nd degree burns across back" are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the 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.No remedial action / corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Batch: aw2091 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.Based on the complaint narrative the preliminary investigation findings suggest burns occurred while used by the customer.The customer sustained an injury of first and second degree burns.The review of the current information suggests there was a product malfunction that contributed to the injury.The root cause category is non assignable (complaint not confirmed as a quality defect).The return sample evaluation does not confirm the complaint for the consumer receiving burns.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "1st and 2nd degree burns." the cause of the consumer stating the wrap caused "1st and 2nd degree burns" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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 adverse event/serious / unknown.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass adverse event / serious/unknown, adverse event safety request for investigation and adverse event negligible-minor for lbh 8 hr products.Site sample was received at the site.Return sample evaluation: one wrap- cells are hard appeared to have brine.Wrap is soiled.
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Manufacturer Narrative
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Batch aw2091 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.Based on the complaint narrative the preliminary investigation findings suggest burns occurred while used by the customer.The customer sustained an injury of first and second degree burns.The review of the current information suggests there was a product malfunction that contributed to the injury.The root cause category is non assignable (complaint not confirmed as a quality defect).The return sample evaluation does not confirm the complaint for the consumer receiving burns.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "1st and 2nd degree burns." the cause of the consumer stating the wrap caused "1st and 2nd degree burns" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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 adverse event/serious/unknown.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass adverse event/serious/unknown, adverse event safety request for investigation and adverse event negligible-minor for lbh 8hr products.Site sample was received at the site.Return sample evaluation: one wrap- cells are hard appeared to have brine.Wrap is soiled.
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Event Description
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Event verbatim [preferred term] 1st and 2nd degree burns across my back from the product [burns first degree], 1st and 2nd degree burns across my back from the product/possible chemical burns/thermal burns/caused a great deal of pain/2nd burns with blisters to scabs to burn area [burns second degree], , narrative: this is a spontaneous report from a contactable consumer (patient).A 65-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number aw2091, expiration date feb2022) on 19jan2020 for severe low back pain.Relevant medical history included ongoing rheumatoid arthritis (currently under the care of a physician) and she was not pregnant, post-menopausal.She had dark or olive skin, did not have sensitive skin and did not have any abnormal skin conditions.Concomitant medications were none.On 19jan2020, the patient used the product as therapy for severe low back pain.She had never used thermacare heatwrap or other heat products for pain relief before.She used it for 4 hours.As a result, on the same day she experienced 1st and 2nd degree burns across back from the product causing possible chemical burns/thermal burns.It caused a great deal of pain and days off work and a great loss of money and possible disfigurement.She got burned by the product.This needed to be rectified immediately so it didn't happen again.She then specified that she experienced 2nd burns with blisters to scabs to burn area.She checked her skin under the product every 2 hours while wearing it.The product was not directly on skin.She did not engage in exercise while using it.She read the usage instruction before using the product.She was not admitted to hospital and did not receive any treatment in response to the events.She did not consult a healthcare professional for the events.She had remaining product.At the time of the report, she was no longer using the product and was still experiencing the events.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on 19jan2020.The outcome of the events was not recovered.According to the product quality complaint group: reasonably suggest device malfunction: yes.Severity of harm was provided as s3.Batch aw2091 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.Based on the complaint narrative the preliminary investigation findings suggest burns occurred while used by the customer.The customer sustained an injury of first and second degree burns.The review of the current information suggests there was a product malfunction that contributed to the injury.The root cause category is non assignable (complaint not confirmed as a quality defect).The return sample evaluation does not confirm the complaint for the consumer receiving burns.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "1st and 2nd degree burns." the cause of the consumer stating the wrap caused "1st and 2nd degree burns" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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 adverse event/serious/unknown.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass adverse event/serious/unknown, adverse event safety request for investigation and adverse event negligible-minor for lbh 8hr products.Sample was received at the site.Return sample evaluation: one wrap- cells are hard appeared to have brine.Wrap is soiled.According to the product quality complaint group on 15oct2020: reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status: received at the site on 19feb2020.Amendment: this follow-up report is being submitted to amend previously reported information: malfunction field ticked yes as this case was also a reportable malfunction mdr.Follow-up (18feb2020): new information from the same contactable consumer included: patient's data, device lot number and expiration date, start date of the product and continuing status (no longer using it), medical history, concomitant medications (none), onset date of the events, details on device use, specification that the patient experienced 2nd burns with blisters to scabs to burn area, information that the patient was not admitted to hospital and did not receive any treatment in response to the events and clinical outcome of the events.Follow-up (07mar2020): new information received from the product quality complaint group included investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (28aug2020): new information received from product quality complaint group included updated investigational results, sample was received at the site.Follow-up attempts are completed.No further information is expected.Follow-up (15oct2020): new information received from the product quality complaint group included: updated reasonably suggest device malfunction and severity of harm assessment and date when the return sample was received at the site.Follow-up attempts are completed.No further information is expected, comment: based on the information provided, the events "1st and 2nd degree burns across back" are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the 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.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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