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| Lot Number AR0096 |
| Device Problems
Use of Device Problem (1670); Patient-Device Incompatibility (2682)
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| Patient Problem
Burn, Thermal (2530)
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| Event Date 12/01/2019 |
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Event Type
Injury
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Event Description
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Burn is her lower back above the panty line, it blistered her skin [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer or other non hcp.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number ar0096, expiration date jan2020) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On (b)(6) 2019, the patient reported she applied the heatwrap about 11am that morning and took it off around 5pm.She stated the heatwrap burned her and blistered her skin.The patient mentioned the location of the burn is her lower back above the panty line.She intended to see a physician as a result of the event.The packaging was sealed and intact.Action taken with the suspect product was unknown.Clinical outcome of the event was not resolved.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event of "burned her and blistered her skin" 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.Comment: based on the information provided, the event of "burned her and blistered her skin" 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] burn is her lower back above the panty line, it blistered her skin [burns second degree].Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number ar0096, expiration date jan2020) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On (b)(6) 2019, the patient reported she applied the heatwrap about 11am that morning and took it off around 5pm.She stated the heatwrap burned her and blistered her skin.The patient mentioned the location of the burn is her lower back above the panty line.She intended to see a physician as a result of the event.The packaging was sealed and intact.The box was available but the wrap itself has been discarded.Action taken with the suspect product was unknown.Clinical outcome of the event was not resolved.According to product quality complaint group: severity of harm is s3.Pfizer device complaint handling unit (dchu) conclusion: 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, the patient sustained a burn injury with a blister after product use.Review of complaint description concludes there is no device malfunction.Site sample status: not received.Additional information has been requested and will be provided as it becomes available.Follow-up(19dec2019): new information received from product quality complaint group includes malfunction and severity assessment from dchu.Company clinical evaluation comment: based on the information provided, the event of "burned her and blistered her skin" 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., comment: based on the information provided, the event of "burned her and blistered her skin" 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] burn is her lower back above the panty line, it blistered her skin [burns second degree] , symptoms have resolved, except for the scar [scar] , did not check her skin under the product while wearing thermacare [intentional device misuse].Case narrative:this is a spontaneous report from a contactable consumer.A 55-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number ar0096, expiration date jan2020) from an unspecified date for discomfort in lower back.The patient's medical history included pain from an unspecified date.The patient's concomitant medication included ibuprofen (advil) started on (b)(6) (unspecified year) and stopped on an unspecified date for pain.Medical history included pain.Past drug history included thermacare heatwrap and no adverse event was reported.On (b)(6) 2019, the patient reported she applied the heatwrap about 11am that morning and took it off around 5pm.She stated the heatwrap burned her and blistered her skin.The event did not require hospitalization and the patient received a cream as treatment for the event.The patient mentioned the location of the burn is her lower back above the panty line.She intended to see a physician as a result of the event.The patient had a scar and went to see the doctor.The packaging was sealed and intact.The box was available but the wrap itself has been discarded.She classified her skin tone as medium and she does not have sensitive skin or any abnormal skin conditions.The color of the box was red and there is product remaining.She used it 2 days in a row for 6 hours a day.She has previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) in (b)(6) 2019 for 2 hours and had previously experienced a problem/symptom with one of these products.She did not engage in exercise while using the product and did not check her skin under the product while wearing thermacare.She read the usage instructions on thermacare before she used the product.She experienced the event after 6 hours of wearing thermacare heatwrap and the symptoms have resolved, except for the scar.The symptom lasted for 4 days with only the scar remaining.She consulted a healthcare professional for the problem and went for something after just showed her the blister.Action taken with the suspect product was unknown.The clinical outcome was not resolved for the event scar and recovered for the event "burned her and blistered her skin." the remaining event outcome was unknown.According to product quality complaint group: severity of harm is s3.Conclusion: 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, the patient sustained a burn injury with a blister after product use.Review of complaint description concludes there is no device malfunction.Site sample status: not received.Additionally, product quality complaints provided the following information on 06jan2020: there was reasonable suggestion of device malfunction.Batch ar0096 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.Final confirmation status: not confirmed.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports,"states it blistered her skin." the cause of the wrap causing blisters 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.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Additional information has been requested and will be provided as it becomes available.Follow-up(19dec2019): new information received from product quality complaint group includes malfunction and severity assessment from dchu.Follow-up (06jan2020 and 10jan2020): new information from product quality complaints includes: investigation results; and from a contactable consumer includes: patient information (added birthdate, age, units, height, and weight), medical history, product information (added indication), concomitant medication, past drug history, and treatment information, new events (scar, intentional device misuse) and details of the event.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment based on the information provided, the events burns second degree, scar and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events burns second degree, scar and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Batch ar0096 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.Final confirmation status: not confirmed.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports,"states it blistered her skin." the cause of the wrap causing blisters 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.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.
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Manufacturer Narrative
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Severity of harm is s3.Conclusion: 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, the patient sustained a burn injury with a blister after product use.Review of complaint description concludes there is no device malfunction.Site sample status: not received.Additionally, product quality complaints provided the following information on 06jan2020: there was reasonable suggestion of device malfunction.Batch ar0096 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.Final confirmation status: not confirmed.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports,"states it blistered her skin." the cause of the wrap causing blisters 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.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.
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Event Description
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Event verbatim [preferred term] burn is her lower back above the panty line, it blistered her skin [burns second degree] , symptoms have resolved, except for the scar [scar] , did not check her skin under the product while wearing thermacare [intentional device misuse].Case narrative:this is a spontaneous report from a contactable consumer.A 55-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number ar0096, expiration date jan2020) from an unspecified date for discomfort in lower back.The patient's medical history included pain from an unspecified date.The patient's concomitant medication included ibuprofen (advil) started on (b)(6)(unspecified year) and stopped on an unspecified date for pain.Past drug history included thermacare heatwrap and no adverse event was reported.On (b)(6) 2019, the patient reported she applied the heatwrap about 11am that morning and took it off around 5pm.She stated the heatwrap burned her and blistered her skin.The event did not require hospitalization and the patient received a cream as treatment for the event.The patient mentioned the location of the burn is her lower back above the panty line.She intended to see a physician as a result of the event.The patient had a scar and went to see the doctor.The packaging was sealed and intact.The box was available but the wrap itself has been discarded.She classified her skin tone as medium and she does not have sensitive skin or any abnormal skin conditions.The color of the box was red and there is product remaining.She used it 2 days in a row for 6 hours a day.She has previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) in (b)(6) 2019 for 2 hours and had previously experienced a problem/symptom with one of these products.She did not engage in exercise while using the product and did not check her skin under the product while wearing thermacare.She read the usage instructions on thermacare before she used the product.She experienced the event after 6 hours of wearing thermacare heatwrap and the symptoms have resolved, except for the scar.The symptom lasted for 4 days with only the scar remaining.She consulted a healthcare professional for the problem and went for something after just showed her the blister.Action taken with the suspect product was unknown.The clinical outcome was not resolved for the event scar and recovered for the event "burned her and blistered her skin." the remaining event outcome was unknown.According to product quality complaint group: severity of harm is s3.Conclusion: 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, the patient sustained a burn injury with a blister after product use.Review of complaint description concludes there is no device malfunction.Site sample status: not received.Additionally, product quality complaints provided the following information on 06jan2020: there was reasonable suggestion of device malfunction.Batch ar0096 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.Final confirmation status: not confirmed.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports,"states it blistered her skin." the cause of the wrap causing blisters 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.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Additional information has been requested and will be provided as it becomes available.Follow-up(19dec2019): new information received from product quality complaint group includes malfunction and severity assessment from dchu.Follow-up (06jan2020 and 10jan2020): new information from product quality complaints includes: investigation results; and from a contactable consumer includes: patient information (added birthdate, age, units, height, and weight), medical history, product information (added indication), concomitant medication, past drug history, and treatment information, new events (scar, intentional device misuse) and details of the event.Follow-up attempts are completed.No further information is expected.Amendment: this follow-up is being submitted to amend previously reported information: product problem box checked.Company clinical evaluation comment: based on the information provided, the events burns second degree, scar and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events burns second degree, scar and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Event Description
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Event verbatim [preferred term] did not check her skin under the product while wearing thermacare [intentional device misuse], burn is her lower back above the panty line, it blistered her skin [burns second degree], symptoms have resolved, except for the scar [scar], , narrative: this is a spontaneous report from a contactable consumer.A 55-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number ar0096, expiration date jan2020) from (b)(6) 2019 for discomfort in lower back.The patient's medical history included pain from an unspecified date.The patient's concomitant medication included ibuprofen (advil) started on (b)(6) (unspecified year) and stopped on an unspecified date for pain.Past drug history included thermacare heatwrap and no adverse event was reported.On (b)(6) 2019, the patient reported she applied the heatwrap about 11am that morning and took it off around 5pm.She stated the heatwrap burned her and blistered her skin.The event did not require hospitalization and the patient received a cream as treatment for the event.The patient mentioned the location of the burn is her lower back above the panty line.She intended to see a physician as a result of the event.The patient had a scar and went to see the doctor.The packaging was sealed and intact.The box was available but the wrap itself has been discarded.She classified her skin tone as medium and she does not have sensitive skin or any abnormal skin conditions.The color of the box was red and there is product remaining.She used it 2 days in a row for 6 hours a day.She has previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) in (b)(6) 2019 for 2 hours and had previously experienced a problem/symptom with one of these products.She did not engage in exercise while using the product and did not check her skin under the product while wearing thermacare.She read the usage instructions on thermacare before she used the product.She experienced the event after 6 hours of wearing thermacare heatwrap and the symptoms have resolved, except for the scar.The symptom lasted for 4 days with only the scar remaining.She consulted a healthcare professional for the problem and went for something after just showed her the blister.Action taken with the suspect product was unknown.The clinical outcome was not resolved for the event scar and recovered for the event "burned her and blistered her skin" on (b)(6) 2019.The remaining event outcome was unknown.According to product quality complaint group: severity of harm is s3.Site sample status: not received.Batch ar0096 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.Final confirmation status: not confirmed.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports, "states it blistered her skin." the cause of the wrap causing blisters is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the fifth complaint for the sub class adverse event /serious/unknown received at the albany site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing root cause for the subclass, per sop-#-complaint trending guide - effective date: (b)(6) 2019.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment & rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this complaints intake, triage and investigation (citi)customizable search, there is not a trend identified for the subclass of adverse event/serious/unknown for lbh products, see attached trending graph lbh ae serious unknown (b)(6) 2016to (b)(6) 2019.This investigation was reopened on (b)(6)2020 to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from sop-#, complaint trending guidelines, effective dates (b)(6) 2019 and (b)(6)2020.A notification of nonconformance was opened pr-#.This deviation will not change the conclusion of the investigation.Follow-up(19dec2019): new information received from product quality complaint group includes malfunction and severity assessment from dchu.Follow-up (06jan2020 and 10jan2020): new information from product quality complaints includes: investigation results; and from a contactable consumer includes: patient information (added birthdate, age, units, height, and weight), medical history, product information (added indication), concomitant medication, past drug history, and treatment information, new events (scar, intentional device misuse) and details of the event.Follow-up attempts are completed.No further information is expected.Amendment: this follow-up is being submitted to amend previously reported information: product problem box checked.Follow-up (08oct2020): new information from product quality complaints includes: updated trend information.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Site sample status: not received.Batch ar0096 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.Final confirmation status: not confirmed.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports, "states it blistered her skin." the cause of the wrap causing blisters is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the fifth complaint for the sub class adverse event /serious/unknown received at the albany site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing root cause for the subclass, per sop-#-complaint trending guide - effective date: (b)(6) 2019.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment & rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this complaints intake, triage and investigation (citi)customizable search, there is not a trend identified for the subclass of adverse event/serious/unknown for lbh products, see attached trending graph lbh ae serious unknown (b)(6)2016 to (b)(6)2019.This investigation was reopened on (b)(6)2020 to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from sop-#, complaint trending guidelines, effective dates (b)(6) 2019and (b)(6)2020.A notification of nonconformance was opened pr-#.This deviation will not change the conclusion of the investigation.
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Search Alerts/Recalls
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