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| Lot Number AR009602/15 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Swelling (2091); Tingling (2171); Partial thickness (Second Degree) Burn (2694)
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| Event Date 04/24/2019 |
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Event Type
Injury
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Event Description
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She got blisters all over her back/she felt start tingling/it started to burn/severe burns on her back/they worsened [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer reporting for herself.A (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number ar009602/15, expiration date jan2020, via an unspecified route of administration from (b)(6) 2019 for muscle pull in back/ muscle hurt.Medical history included she hurt her back.Concomitant medication included ibuprofen (motrin) for muscle ache.She previously used thermacare heatwraps and never experienced below problem.The patient purchased thermacare heatwraps back pain therapy on her own and wore it on (b)(6) 2019 for like 20 minutes and she got blisters all over her back.That was the first time she used it that day.The blisters were so bad, it did not wear them for so long.She said she shouldn't have severe burns on her back and need to know if this was a recall though.Consumer was requested to visit doctor and nearest emergency room, consumer mentioned she had to go today ((b)(6) 2019) because it was getting worse; she didn't want to get any infection because they were blisters break and then she can get an infection.When probed about the blisters, the patient mentioned, "they worsened because they are under my bra that's why you know step of my bra.There is no really air to breathe in." she has not received any treatment for the event blister.While wearing thermacare she was just wearing a shirt and thermcare and she was sitting on the couch that was it, she wore for half hour then she felt start tingling she pulled it off and pop these burns.She took it off as soon as it started to burn.The patient stated she was not currently under the care of a physician for any medical condition.She denied below conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis.Her skin tone was classified as white.She did not have sensitive skin or any abnormal skin conditions.The color of box purchased was red.There was one product remaining.She did not previously use other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).She did not engage in exercise while using the product.She did read the usage instructions on thermacare before using the product.The action taken for the product was permanently discontinued on (b)(6) 2019.The outcome of the event "she got blisters all over her back/ she felt start tingling/ it started to burn/ severe burns on her back/ they worsened" 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 burns second degree 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] she got blisters all over her back she felt start tingling/ it started to burn/ severe burns on her back they worsened [burns second degree].Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A 48-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number ar009602/15, expiration date jan2020, via an unspecified route of administration from (b)(6) 2019 for muscle pull in back/ muscle hurt.Medical history included "she hurt her back".Concomitant medication included ibuprofen (motrin) for muscle ache.She previously used thermacare heatwraps and never experienced below problem.The patient purchased thermacare heatwraps back pain therapy on her own and wore it on (b)(6) 2019 for like 20 minutes and she got blisters all over her back.That was the first time she used it that day.The blisters were so bad, it did not wear them for so long.She said she shouldn't have severe burns on her back and need to know if this was a recall though.Consumer was requested to visit doctor and nearest emergency room, consumer mentioned she had to go today (b)(6) 2019because it was getting worse; she didn't want to get any infection because they were blisters break and then she can get an infection.When probed about the blisters, the patient mentioned, "they worsened because they are under my bra that's why you know step of my bra.There is no really air to breathe in." she has not received any treatment for the event blister.While wearing thermacare she was just wearing a shirt and thermcare and she was sitting on the couch that was it, she wore for half hour then she felt start tingling she pulled it off and pop these burns.She took it off as soon as it started to burn.The patient stated she was not currently under the care of a physician for any medical condition.She denied below conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis.Her skin tone was classified as white.She did not have sensitive skin or any abnormal skin conditions.The color of box purchased was red.There was one product remaining.She did not previously use other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).She did not engage in exercise while using the product.She did read the usage instructions on thermacare before using the product.As of (b)(6) 2019, it was also reported that the wrap was on for 15 minutes.She was seeking follow-up, but never received it.She was going to pursue a lawyer because of no follow-up.The action taken for the product was permanently discontinued on (b)(6) 2019.The outcome of the event "she got blisters all over her back she felt start tingling/ it started to burn severe burns on her back/ they worsened" was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (b)(6) 2019 and (b)(6) 2019:new information received from a product quality complaint group and the same contactable consumer includes: additional event course details.Company clinical evaluation comment: based on the information provided, the event burns second degree 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 burns second degree 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] she got blisters all over her back/ she felt start tingling/ it started to burn/ severe burns on her back/ they worsened [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A 48-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number ar009602/15, expiration date jan2020, via an unspecified route of administration from 24apr2019 for muscle pull in back/ muscle hurt.Medical history included "she hurt her back".Concomitant medication included ibuprofen (motrin) for muscle ache.She previously used thermacare heatraps for unknown indication and never experienced below problem (no adverse effect).The patient purchased thermacare heatwraps back pain therapy on her own and wore it on (b)(6) 2019 for like 20 minutes and she got blisters all over her back.That was the first time she used it that day.The blisters were so bad, it did not wear them for so long.She said she shouldn't have severe burns on her back and need to know if this was a recall though.Consumer was requested to visit doctor and nearest emergency room, consumer mentioned she had to go today ((b)(6) 2019) because it was getting worse; she didn't want to get any infection because they were blisters break and then she can get an infection.When probed about the blisters, the patient mentioned, "they worsened because they are under my bra that's why you know step of my bra.There is no really air to breathe in." she has not received any treatment for the event blister.While wearing thermacare she was just wearing a shirt and thermcare and she was sitting on the couch that was it, she wore for half hour then she felt start tingling she pulled it off and pop these burns.She took it off as soon as it started to burn.The patient stated she was not currently under the care of a physician for any medical condition.She denied below conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis.Her skin tone was classified as white.She did not have sensitive skin or any abnormal skin conditions.The color of box purchased was red.There was one product remaining.She did not previously use other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).She did not engage in exercise while using the product.She did read the usage instructions on thermacare before using the product.As of (b)(6) 2019, it was also reported that the wrap was on for 15 minutes.She was seeking follow-up, but never received it.She was going to pursue a lawyer because of no follow-up.The action taken for the product was permanently discontinued on 25apr2019.The outcome of the event "she got blisters all over her back/ she felt start tingling/ it started to burn/ severe burns on her back/ they worsened" was not resolved.According to the product quality complaint group: subclass: adverse event safety request for investigation.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Complaint confirmed?: no.Notify safety?: no.Final confirmation status: not confirmed.Follow-up (29apr2019 and 29apr2019): new information received from a product quality complaint group and the same contactable consumer includes: additional event course details.Follow-up (28may2019): new information received from product quality complaint group includes investigation results.Company clinical evaluation comment: based on the information provided, the event burns second degree 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.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event burns second degree 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.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Subclass: adverse event safety request for investigation.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Complaint confirmed?: no.Notify safety?: no.Final confirmation status: not confirmed.
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Manufacturer Narrative
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Subclass: adverse event safety request for investigation.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Complaint confirmed?: no.Notify safety?: no.Final confirmation status: not confirmed.An evaluation was made by searching for possible trends for this subclass.The following complaint intake, triage and investigation (citi) search was performed: scope: site notification date: 01may2016 through 31may2019/manufacturing site: pfizer (site name)/complaint class: external cause investigation /complaint sub class: adverse event safety request.The citi search returned a total of 547 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The subclass shows an increase in november 2018 thru january 2019.This is a seasonality change in combination with a change in safety¿s procedure wsr cp001 wi 110, ¿case processing principles product quality complaint guidance¿, updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may 2019.Complaints increased due to consumers reporting adverse events.
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Event Description
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Event verbatim [preferred term] she got blisters all over her back/ she felt start tingling/ it started to burn/ severe burns on her back/ they worsened [burns second degree].Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A 48-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number ar009602/15, expiration date jan2020, via an unspecified route of administration from (b)(6) 2019 for muscle pull in back/ muscle hurt.Medical history included "she hurt her back" and muscle ache.Concomitant medication included ibuprofen (motrin) for muscle ache.She previously used thermacare heatraps for unknown indication and never experienced below problem (no adverse effect).The patient purchased thermacare heatwraps back pain therapy on her own and wore it on (b)(6) 2019 for like 20 minutes and she got blisters all over her back.That was the first time she used it that day.The blisters were so bad, it did not wear them for so long.She said she shouldn't have severe burns on her back and need to know if this was a recall though.Consumer was requested to visit doctor and nearest emergency room, consumer mentioned she had to go today ((b)(6) 2019) because it was getting worse; she didn't want to get any infection because they were blisters break and then she can get an infection.When probed about the blisters, the patient mentioned, "they worsened because they are under my bra that's why you know step of my bra.There is no really air to breathe in." she has not received any treatment for the event blister.While wearing thermacare she was just wearing a shirt and thermcare and she was sitting on the couch that was it, she wore for half hour then she felt start tingling she pulled it off and pop these burns.She took it off as soon as it started to burn.The patient stated she was not currently under the care of a physician for any medical condition.She denied below conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis.Her skin tone was classified as white.She did not have sensitive skin or any abnormal skin conditions.The color of box purchased was red.There was one product remaining.She did not previously use other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).She did not engage in exercise while using the product.She did read the usage instructions on thermacare before using the product.As of (b)(6) 2019 it was also reported that the wrap was on for 15 minutes.She was seeking follow-up, but never received it.She was going to pursue a lawyer because of no follow-up.The action taken for the product was permanently discontinued on (b)(6) 2019.The outcome of the event "she got blisters all over her back/ she felt start tingling/ it started to burn/ severe burns on her back/ they worsened" was not resolved.According to the product quality complaint group: subclass: adverse event safety request for investigation.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Complaint confirmed?: no.Notify safety?: no.Final confirmation status: not confirmed.An evaluation was made by searching for possible trends for this subclass.The following complaint intake, triage and investigation (citi) search was performed: scope: site notification date: 01may2016 through 31may2019/manufacturing site: pfizer (site name)/complaint class: external cause investigation /complaint sub class: adverse event safety request.The citi search returned a total of 547 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The subclass shows an increase in november 2018 thru january 2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may 2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from april 2019.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in april and may 2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.This is also observed in a review of the 36 month trend chart for this subclass.These complaints are classified as an open-pouch.All open pouch complaints are investigated per investigation memo cd-66388 and are not valid adverse events.Based on this citi search, there is not a trend identified for the subclass of adverse events safety request for investigation.Refer to the 36 month trend chart attachment for lbh adverse event safety request investigation may 2016 to may 2019.Upon follow-up 14aug2019, product quality complaint reported that severity of harm was selected by the manufacturing site as s3 (injury, which could result in the need for medical treatment and hospitalization).Follow-up (29apr2019 and 29apr2019): new information received from a product quality complaint group and the same contactable consumer includes: additional event course details.Follow-up (28may2019): new information received from product quality complaint group includes investigation results.Follow-up (01jul2019): follow-up attempts are completed.No further information is expected.Follow-up (09aug2019): new information received from product quality complaint group includes investigation results.Follow-up (14aug2019): new information received from product quality complaint group includes severity rating (s3).Company clinical evaluation comment: based on the information provided, the event burns second degree 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event burns second degree 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.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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Event Description
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Event verbatim [preferred term] she got blisters all over her back/ she felt start tingling/ it started to burn/ severe burns on her back/ they worsened [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A 48-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number ar009602/15, expiration date jan2020, via an unspecified route of administration from (b)(6) 2019 for muscle pull in back/ muscle hurt.Medical history included "she hurt her back" and muscle ache.Concomitant medication included ibuprofen (motrin) for muscle ache.She previously used thermacare heatraps for unknown indication and never experienced below problem (no adverse effect).The patient purchased thermacare heatwraps back pain therapy on her own and wore it on (b)(6) 2019 for like 20 minutes and she got blisters all over her back.That was the first time she used it that day.The blisters were so bad, it did not wear them for so long.She said she shouldn't have severe burns on her back and need to know if this was a recall though.Consumer was requested to visit doctor and nearest emergency room, consumer mentioned she had to go today (25apr2019) because it was getting worse; she didn't want to get any infection because they were blisters break and then she can get an infection.When probed about the blisters, the patient mentioned, "they worsened because they are under my bra that's why you know step of my bra.There is no really air to breathe in." she has not received any treatment for the event blister.While wearing thermacare she was just wearing a shirt and thermcare and she was sitting on the couch that was it, she wore for half hour then she felt start tingling she pulled it off and pop these burns.She took it off as soon as it started to burn.The patient stated she was not currently under the care of a physician for any medical condition.She denied below conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis.Her skin tone was classified as white.She did not have sensitive skin or any abnormal skin conditions.The color of box purchased was red.There was one product remaining.She did not previously use other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).She did not engage in exercise while using the product.She did read the usage instructions on thermacare before using the product.As of (b)(6) 2019, it was also reported that the wrap was on for 15 minutes.She was seeking follow-up, but never received it.She was going to pursue a lawyer because of no follow-up.The action taken for the product was permanently discontinued on (b)(6) 2019.The outcome of the event "she got blisters all over her back/ she felt start tingling/ it started to burn/ severe burns on her back/ they worsened" was not resolved.According to the product quality complaint group: subclass: adverse event safety request for investigation.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Complaint confirmed?: no.Notify safety?: no.Final confirmation status: not confirmed.An evaluation was made by searching for possible trends for this subclass.The following complaint intake, triage and investigation (citi) search was performed: scope: site notification date: 01may2016 through 31may2019/manufacturing site: pfizer (site name)/complaint class: external cause investigation /complaint sub class: adverse event safety request.The citi search returned a total of 547 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The subclass shows an increase in november 2018 thru january 2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may 2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from april 2019.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in april and may 2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.This is also observed in a review of the 36 month trend chart for this subclass.These complaints are classified as an open-pouch.All open pouch complaints are investigated per investigation memo cd-66388 and are not valid adverse events.Based on this citi search, there is not a trend identified for the subclass of adverse events safety request for investigation.Refer to the 36 month trend chart attachment for lbh adverse event safety request investigation (b)(6) 2019.Follow-up (29apr2019 and 29apr2019): new information received from a product quality complaint group and the same contactable consumer includes: additional event course details.Follow-up (28may2019): new information received from product quality complaint group includes investigation results.Follow-up (01jul2019): follow-up attempts are completed.No further information is expected.Follow-up (09aug2019): new information received from product quality complaint group includes investigation results.Company clinical evaluation comment: based on the information provided, the event burns second degree 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event burns second degree 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Subclass: adverse event safety request for investigation.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Complaint confirmed?: no.Notify safety?: no.Final confirmation status: not confirmed.An evaluation was made by searching for possible trends for this subclass.The following complaint intake, triage and investigation (citi) search was performed: scope: site notification date: 01may2016 through 31may2019/manufacturing site: pfizer (site name)/complaint class: external cause investigation /complaint sub class: adverse event safety request.The citi search returned a total of 547 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The subclass shows an increase in (b)(6) 2019.This is a seasonality change in combination with a change in safety¿s procedure wsr cp001 wi 110, ¿case processing principles product quality complaint guidance¿, updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may 2019.Complaints increased due to consumers reporting adverse events af.
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Event Description
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She got blisters all over her back/ she felt start tingling/ it started to burn/ severe burns on her back/ they worsened [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer reporting for herself.A 48-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number: ar009602/15, expiration date: jan2020, via an unspecified route of administration from on (b)(6) 2019 for muscle pull in back/ muscle hurt.Medical history included "she hurt her back" and muscle ache.Concomitant medication included ibuprofen (motrin) for muscle ache.She previously used thermacare heatraps for unknown indication and never experienced below problem (no adverse effect).The patient purchased thermacare heatwraps back pain therapy on her own and wore it on (b)(6) 2019 for like 20 minutes and she got blisters all over her back.That was the first time she used it that day.The blisters were so bad, it did not wear them for so long.She said she shouldn't have severe burns on her back and need to know if this was a recall though.Consumer was requested to visit doctor and nearest emergency room.Consumer mentioned she had to go today (on (b)(6) 2019) because it was getting worse; she didn't want to get any infection because they were blisters break and then she can get an infection.When probed about the blisters, the patient mentioned, "they worsened because they are under my bra that's why you know step of my bra.There is no really air to breathe in." she has not received any treatment for the event blister.While wearing thermacare she was just wearing a shirt and thermcare and she was sitting on the couch that was it, she wore for half hour then she felt start tingling she pulled it off and pop these burns.She took it off as soon as it started to burn.The patient stated she was not currently under the care of a physician for any medical condition.She denied below conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis.Her skin tone was classified as white.She did not have sensitive skin or any abnormal skin conditions.The color of box purchased was red.There was one product remaining.She did not previously use other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).She did not engage in exercise while using the product.She did read the usage instructions on thermacare before using the product.As of on (b)(6) 2019, it was also reported that the wrap was on for 15 minutes.She was seeking follow-up, but never received it.She was going to pursue a lawyer because of no follow-up.The action taken for the product was permanently discontinued on 25apr2019.The outcome of the event "she got blisters all over her back/ she felt start tingling/ it started to burn/ severe burns on her back/ they worsened" was not resolved.According to the product quality complaint group: subclass: adverse event safety request for investigation.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Complaint confirmed?: no.Notify safety?: no.Final confirmation status: not confirmed.An evaluation was made by searching for possible trends for this subclass.The following complaint intake, triage and investigation (citi) search was performed: scope: site notification date: 01may2016 through 31may2019/manufacturing site: pfizer (site name)/complaint class: external cause investigation /complaint sub class: adverse event safety request.The citi search returned a total of 547 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The subclass shows an increase in november 2018 thru january 2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may 2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches: s00639, s23902, s97473 and w37940 from april 2019.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in april and may 2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.This is also observed in a review of the 36 month trend chart for this subclass.These complaints are classified as an open-pouch.All open pouch complaints are investigated per investigation memo cd-66388 and are not valid adverse events.Based on this citi search, there is not a trend identified for the subclass of adverse events safety request for investigation.Refer to the 36 month trend chart attachment for lbh adverse event safety request investigation may 2016 to may 2019.Upon follow-up 14aug2019, product quality complaint reported that severity of harm was selected by the manufacturing site as s3 (injury, which could result in the need for medical treatment and hospitalization).Product quality complaints provided the following investigation information for lot#: ar0096 on 15aug2020: 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 "blisters." 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.Batch: ar0096 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c to 41.6°c) per spec-#; effective date: 07nov2018.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.The visual inspection of a retain sample included one carton and the two pouched wraps inside and shows no obvious defects.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event /serious/unknown received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch based on citi customizable search, there is not a trend identified for the subclass of adverse event/serious/unknown for lbh products.Site sample status was not received.There was reasonable suggestion of device malfunction.Severity of harm was s3 for burn/blisters.Follow-up (29apr2019 and 29apr2019): new information received from a product quality complaint group and the same contactable consumer includes: additional event course details.Follow-up (28may2019): new information received from product quality complaint group includes investigation results.Follow-up (01jul2019): follow-up attempts are completed.No further information is expected.Follow-up (09aug2019): new information received from product quality complaint group includes investigation results.Follow-up (14aug2019): new information received from product quality complaint group includes severity rating (s3).Follow-up (15aug2019): new information from product quality complaint group includes: investigation results for lot#: ar00960.Company clinical evaluation comment: based on the information provided, the event burns second degree 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the information provided, the event burns second degree 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.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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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 "blisters." 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.Batch: ar0096 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c to 41.6°c) per spec-#; effective date: 07nov2018.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.The visual inspection of a retain sample included one carton and the two pouched wraps inside and shows no obvious defects.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event /serious/unknown received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch based on citi customizable search, there is not a trend identified f.
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Search Alerts/Recalls
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