|
|
| Lot Number T48943 |
| Device Problem
Material Integrity Problem (2978)
|
| Patient Problems
Skin Discoloration (2074); Burn, Thermal (2530); Patient Problem/Medical Problem (2688); Partial thickness (Second Degree) Burn (2694)
|
| Event Date 10/24/2018 |
|
Event Type
Injury
|
|
Event Description
|
|
Event verbatim [preferred term] chemical burn/huge black rectangle mark with open little blisters [burns second degree], i was not feeling too well [feeling abnormal].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) from 2018 at an unspecified frequency for sore back and some stiffness.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient previously used thermacare lower back & hip about a year ago (in 2017) and never had any issues with it.The patient reported that she purchased the product on (b)(6) 2018.She put it on in the bathroom at work on an unspecified date in 2018.She left work about 4 hours after that and then took it off.She went to bed because she was not feeling too well and then the next morning her husband saw her back and freaked out.It was a huge black rectangle mark with open little blisters.She went to the doctor and was told that this was a chemical burn.She prescribed ascend antibiotic cream for the burn however the discoloration has not left and there was this huge black mark on her back.The box states "provides up to 8 hrs of heat while you wear it plus 8 hours after you take it off".The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "burn blister" is described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "feeling unwell" is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "burn blister" is described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "feeling unwell" is non-serious.The events are medically assessed as associated with the use of the device.
|
| |
|
Manufacturer Narrative
|
|
The root cause category is non-assignable (complaint not confirmed).Our 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.No trend has been identified for lbh product for the subclass of adverse event safety request for investigation.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse events safety request for investigation for lbh products.There is no further action required.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] chemical burn/huge black rectangle mark with open little blisters/2nd degree burn to lower back [burns second degree] , i was not feeling too well [feeling abnormal] , skin color darkening [skin discolouration] ,.Case narrative:this is a spontaneous report from a contactable consumer and a contactable nurse.A 41-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) from 2018 at an unspecified frequency for sore back and some stiffness.The patient medical history included epilepsy.The patient's concomitant medications were not reported.The patient previously used thermacare lower back & hip about a year ago (in 2017) and never had any issues with it, previously used phenytoin and experienced drug allergy.The patient reported that she purchased the product on (b)(6) 2018.She put it on in the bathroom at work on 04nov2018.She left work about 4 hours after that and then took it off.She went to bed because she was not feeling too well on (b)(6) 2018 and then the next morning 05nov2018 her husband saw her back and freaked out.It was a huge black rectangle mark with open little blisters.She went to the doctor and was told that this was a chemical burn.She prescribed ascend antibiotic cream for the burn however the discoloration had not left and there was this huge black mark on her back.The box stated "provides up to 8 hrs of heat while you wear it plus 8 hours after you take it off".The nurse further reported that the patient provided information to her regarding the reported adverse events with the use of the product.The patient experienced 2nd degree burn to lower back on 05nov2018.She was not admitted to hospital.She received silvadene cream applied to area twice a day as treatment.The patient also experienced skin color darkening on an unspecified date.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event chemical burn/huge black rectangle mark with open little blisters/2nd degree burn to lower back was resolving and the outcome of the other events was unknown.The nurse considered that there was a reasonable possibility that the event 2nd degree burn to lower back was related to thermacare heatwrap.Sample status was not requested.Product investigation summary results were as follows: the root cause category is non-assignable (complaint not confirmed).Our 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.No trend has been identified for lbh product for the subclass of adverse event safety request for investigation.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse events safety request for investigation for lbh products.There is no further action required.Follow-up (08feb2019): new information reported from product quality complaints includes product investigation summary results.Follow up (15apr2019): new information received from a contactable nurse includes new reporter, patient data (age, weight, height), medical history, past drug data, new event (skin color darkening), onset of event, outcome of event, deny of hospitalization, treatment details, event details and causality assessment.Company clinical evaluation comment: based on the information provided, the events of "burn blister" is described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events "feeling unwell" and "skin color darkening" are non-serious.The events are 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.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 events of "burn blister" is described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events "feeling unwell" and "skin color darkening" are non-serious.The events are medically assessed as associated with the use of the device.Based on the information provided, the events of "burn blister" is described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events "feeling unwell" and "skin color darkening" are non-serious.The events are 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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
|
| |
|
Event Description
|
|
Chemical burn/huge black rectangle mark with open little blisters [burns second degree], i was not feeling too well [feeling abnormal].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) from 2018 at an unspecified frequency for sore back and some stiffness.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient previously used thermacare lower back & hip about a year ago (in 2017) and never had any issues with it.The patient reported that she purchased the product on 22oct2018.She put it on in the bathroom at work on an unspecified date in 2018.She left work about 4 hours after that and then took it off.She went to bed because she was not feeling too well and then the next morning her husband saw her back and freaked out.It was a huge black rectangle mark with open little blisters.She went to the doctor and was told that this was a chemical burn.She prescribed ascend antibiotic cream for the burn however the discoloration has not left and there was this huge black mark on her back.The box states "provides up to 8 hrs of heat while you wear it plus 8 hours after you take it off".The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Sample status was not requested.Product investigation summary results were as follows: the root cause category is non-assignable (complaint not confirmed).Our 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.No trend has been identified for lbh product for the subclass of adverse event safety request for investigation.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse events safety request for investigation for lbh products.There is no further action required.Additional information has been requested and will be provided as it becomes available.Follow-up (08feb2019): new information reported from product quality complaints includes product investigation summary results.Company clinical evaluation comment: based on the information provided, the events of "burn blister" is described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "feeling unwell" is non-serious.The events are 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.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 events of "burn blister" is described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "feeling unwell" is non-serious.The events are 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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
|
| |
|
Manufacturer Narrative
|
|
The root cause category is non-assignable (complaint not confirmed).Our 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.No trend has been identified for lbh product for the subclass of adverse event safety request for investigation.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse events safety request for investigation for lbh products.There is no further action required.
|
| |
|
Manufacturer Narrative
|
|
The root cause category is non-assignable (complaint not confirmed).Our 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.No trend has been identified for lbh product for the subclass of adverse event safety request for investigation.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse events safety request for investigation for lbh products.There is no further action required.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] chemical burn/huge black rectangle mark with open little blisters/2nd degree burn to lower back/ my back was really red/redness [burns second degree] , i was not feeling too well [feeling abnormal] , skin color darkening/mark & discoloration still there/huge rectangle black mark [skin discolouration] , back was itchy [pruritus] ,.Case narrative:this is a spontaneous report from a contactable consumer and a contactable nurse.A 41-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number and expiration date: t48943, oct2020, on (b)(6) 2018 at an unspecified frequency for sore back and some stiffness/ stiff & achy lower back pain.The patient medical history included epilepsy.There were no concomitant medications.The patient previously used thermacare lower back & hip about a year ago (in 2017) and never had any issues with it (used for 3 days), previously used phenytoin and experienced drug allergy.The patient previously used other heat products for pain relief during 2017 for 1-2 days, and never experienced a problem/ symptoms with these products.The patient reported that she purchased the product on (b)(6) 2018.The patient used 1 thermacare heatwrap on (b)(6) 2018 for 4 or 5 hours.She put it on in the bathroom at work.She left work about 4 hours after that and then took it off.She went to bed / took a nap because she was not feeling too well.The patient did not receive any treatment for not feeling too well.Then the next morning (b)(6) 2018, she was taking a shower and her back was itchy.She got out of shower and noticed blisters and her back was really red with dark mark.Her husband saw her back and freaked out.It was a huge black rectangle mark with open little blisters.The patient experienced 2nd degree burn to lower back.She received silvadene cream applied to area twice a day as treatment.She consulted a nurse and doctor for the events, and when she went to the doctor she was told that this was a chemical burn.She prescribed silver sulfadiazine (ascend) cream for the burn however the discoloration had not left and there was this huge black mark on her back.The patient experienced skin color darkening.There was no treatment for the skin color darkening.She was not admitted to hospital for any of the reported events.The product was purchased in a red box, and the box stated "provides up to 8 hrs of heat while you wear it plus 8 hours after you take it off".The patient was not under the care of a physician for any medical conditions, and did not have any abnormal skin conditions or sensitive skin.The patient classified her skin tone as dark or olive.The patient attached the adhesive to body, as directed, and confirmed she was under 55 years of age.She read the directions before use, checked the product frequently, and took it off after 4/5 hrs.The action taken in response to the events for thermacare heatwrap was permanently withdrawn 24oct2018, after seeing the blister form and redness.The blisters/ redness lasted 2/3 weeks.The huge rectangle black mark/ discoloration was still there.Her dr was not sure if it would go away.She is to make an appointment with a dermatologist to see if the black discoloration and rectangle will go away.The outcome of the event chemical burn/huge black rectangle mark with open little blisters/2nd degree burn to lower back and skin discoloration was not recovered.She recovered from not feeling too well on an unspecified date.The outcome of back was itchy was unknown.The nurse further reported that the patient provided information to her regarding the reported adverse events with the use of the product.The nurse considered that there was a reasonable possibility that the event 2nd degree burn to lower back was related to thermacare heatwrap.Sample status was not requested.Product investigation summary results were as follows: the root cause category is non-assignable (complaint not confirmed).Our 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.No trend has been identified for lbh product for the subclass of adverse event safety request for investigation.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse events safety request for investigation for lbh products.There is no further action required.Follow-up (08feb2019): new information reported from product quality complaints includes product investigation summary results.Follow up (15apr2019): new information received from a contactable nurse includes new reporter, patient data (age, weight, height), medical history, past drug data, new event (skin color darkening), onset of event, outcome of event, deny of hospitalization, treatment details, event details and causality assessment.Follow-up (06may2019): new information from a contactable consumer includes: product information (administration dates, details, action taken), concomitant medications (none), patient history, updated event information (event onset dates and new events: back was itchy, back was really red), additional treatment details, hospital admission status (none), and event outcome.Company clinical evaluation comment: based on the information provided, the event of burns second degree is described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events feeling abnormal, skin discolouration and pruritus are non-serious.The events are 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.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 of burns second degree is described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events feeling abnormal, skin discolouration and pruritus are non-serious.The events are 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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
|
| |
|
Manufacturer Narrative
|
|
Initial complaint assessment: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: scope: date contacted: 01dec2015 through 31dec2018/manufacturing site: (site name)/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 258 complaints for lower back and hip products during this time period for the class/subclass.Of the 258 complaints; 29 complaints has the batch number recorded as ¿unknown¿.The 229 remaining complaints were evaluated.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse events safety request for investigation for lbh products.There is no further action required.Based on this pcom search for the subclass of adverse event safety request for investigation for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for lbh products, refer to attachment for adverse event lbh dec2015 - dec2018.The root cause category is non-assignable (complaint not confirmed).Our 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.No trend has been identified for lbh product for the subclass of adverse event safety request for investigation.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] chemical burn/huge black rectangle mark with open little blisters/2nd degree burn to lower back/ my back was really red/redness [burns second degree] , i was not feeling too well [feeling abnormal] , skin color darkening/mark & discoloration still there/huge rectangle black mark [skin discolouration] , back was itchy [pruritus] ,.Case narrative:this is a spontaneous report from a contactable consumer and a contactable nurse.A 41-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number and expiration date: t48943, oct2020, on (b)(6) 2018 at an unspecified frequency for sore back and some stiffness/ stiff & achy lower back pain.The patient medical history included epilepsy.There were no concomitant medications.The patient previously used thermacare lower back & hip about a year ago (in 2017) and never had any issues with it (used for 3 days), previously used phenytoin and experienced drug allergy.The patient previously used other heat products for pain relief during 2017 for 1-2 days, and never experienced a problem/ symptoms with these products.The patient reported that she purchased the product on (b)(6) 2018.The patient used 1 thermacare heatwrap on (b)(6) 2018 for 4 or 5 hours.She put it on in the bathroom at work.She left work about 4 hours after that and then took it off.She went to bed / took a nap because she was not feeling too well.The patient did not receive any treatment for not feeling too well.Then the next morning (b)(6) 2018, she was taking a shower and her back was itchy.She got out of shower and noticed blisters and her back was really red with dark mark.Her husband saw her back and freaked out.It was a huge black rectangle mark with open little blisters.The patient experienced 2nd degree burn to lower back.She received silvadene cream applied to area twice a day as treatment.She consulted a nurse and doctor for the events, and when she went to the doctor she was told that this was a chemical burn.She prescribed silver sulfadiazine (ascend) cream for the burn however the discoloration had not left and there was this huge black mark on her back.The patient experienced skin color darkening.There was no treatment for the skin color darkening.She was not admitted to hospital for any of the reported events.The product was purchased in a red box, and the box stated "provides up to 8 hrs of heat while you wear it plus 8 hours after you take it off".The patient was not under the care of a physician for any medical conditions, and did not have any abnormal skin conditions or sensitive skin.The patient classified her skin tone as dark or olive.The patient attached the adhesive to body, as directed, and confirmed she was under 55 years of age.She read the directions before use, checked the product frequently, and took it off after 4/5 hrs.The action taken in response to the events for thermacare heatwrap was permanently withdrawn (b)(6) 2018, after seeing the blister form and redness.The blisters/ redness lasted 2/3 weeks.The huge rectangle black mark/ discoloration was still there.Her dr was not sure if it would go away.She is to make an appointment with a dermatologist to see if the black discoloration and rectangle will go away.The outcome of the event chemical burn/huge black rectangle mark with open little blisters/2nd degree burn to lower back and skin discoloration was not recovered.She recovered from not feeling too well on an unspecified date.The outcome of back was itchy was unknown.The nurse further reported that the patient provided information to her regarding the reported adverse events with the use of the product.The nurse considered that there was a reasonable possibility that the event 2nd degree burn to lower back was related to thermacare heatwrap.Sample status was not requested.Product investigation summary results were as follows: initial complaint assessment: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: scope: date contacted: 01dec2015 through 31dec2018/manufacturing site: (site name)/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 258 complaints for lower back and hip products during this time period for the class/subclass.Of the 258 complaints; 29 complaints has the batch number recorded as "unknown".The 229 remaining complaints were evaluated.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse events safety request for investigation for lbh products.There is no further action required.Based on this pcom search for the subclass of adverse event safety request for investigation for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for lbh products, refer to attachment for adverse event lbh dec2015 - dec2018.The root cause category is non-assignable (complaint not confirmed).Our 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.No trend has been identified for lbh product for the subclass of adverse event safety request for investigation.Follow-up (08feb2019): new information reported from product quality complaints includes product investigation summary results.Follow up (15apr2019): new information received from a contactable nurse includes new reporter, patient data (age, weight, height), medical history, past drug data, new event (skin color darkening), onset of event, outcome of event, deny of hospitalization, treatment details, event details and causality assessment.Follow-up (06may2019): new information from a contactable consumer includes: product information (administration dates, details, action taken), concomitant medications (none), patient history, updated event information (event onset dates and new events: back was itchy, back was really red), additional treatment details, hospital admission status (none), and event outcome.Follow-up (17may2019): new information reported from product quality complaints includes product investigation summary results.Company clinical evaluation comment: based on the information provided, the event of burns second degree is described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events feeling abnormal, skin discolouration and pruritus are non-serious.The events are 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.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 of burns second degree is described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events feeling abnormal, skin discolouration and pruritus are non-serious.The events are 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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
|
| |
|
Manufacturer Narrative
|
|
Initial complaint assessment: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: scope: date contacted: (b)(6)2015 through (b)(6)2018/manufacturing site: (site name)/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 258 complaints for lower back and hip products during this time period for the class/subclass.Of the 258 complaints; 29 complaints has the batch number recorded as ¿unknown¿.The 229 remaining complaints were evaluated.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse events safety request for investigation for lbh products.There is no further action required.Based on this pcom search for the subclass of adverse event safety request for investigation for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for lbh products, for adverse event lbh dec2015 - dec2018.The root cause category is non-assignable (complaint not confirmed).Our 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.No trend has been identified for lbh product for the subclass of adverse event safety request for investigation.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] chemical burn/huge black rectangle mark with open little blisters/2nd degree burn to lower back/ my back was really red/redness [burns second degree] , i was not feeling too well [feeling abnormal] , skin color darkening/mark & discoloration still there/huge rectangle black mark [skin discolouration] , back was itchy [pruritus] ,.Case narrative:this is a spontaneous report from a contactable consumer and a contactable nurse.A 41-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number and expiration date: t48943, oct2020, on (b)(6)2018 at an unspecified frequency for sore back and some stiffness/ stiff & achy lower back pain.The patient medical history included epilepsy.There were no concomitant medications.The patient previously used thermacare lower back & hip about a year ago (in 2017) and never had any issues with it (used for 3 days), previously used phenytoin and experienced drug allergy.The patient previously used other heat products for pain relief during 2017 for 1-2 days, and never experienced a problem/ symptoms with these products.The patient reported that she purchased the product on (b)(6)2018.The patient used 1 thermacare heatwrap on (b)(6)2018 for 4 or 5 hours.She put it on in the bathroom at work.She left work about 4 hours after that and then took it off.She went to bed / took a nap because she was not feeling too well.The patient did not receive any treatment for not feeling too well.Then the next morning (b)(6)2018, she was taking a shower and her back was itchy.She got out of shower and noticed blisters and her back was really red with dark mark.Her husband saw her back and freaked out.It was a huge black rectangle mark with open little blisters.The patient experienced 2nd degree burn to lower back.She received silvadene cream applied to area twice a day as treatment.She consulted a nurse and doctor for the events, and when she went to the doctor she was told that this was a chemical burn.She prescribed silver sulfadiazine (ascend) cream for the burn however the discoloration had not left and there was this huge black mark on her back.The patient experienced skin color darkening.There was no treatment for the skin color darkening.She was not admitted to hospital for any of the reported events.The product was purchased in a red box, and the box stated "provides up to 8 hrs of heat while you wear it plus 8 hours after you take it off".The patient was not under the care of a physician for any medical conditions, and did not have any abnormal skin conditions or sensitive skin.The patient classified her skin tone as dark or olive.The patient attached the adhesive to body, as directed, and confirmed she was under 55 years of age.She read the directions before use, checked the product frequently, and took it off after 4/5 hrs.The action taken in response to the events for thermacare heatwrap was permanently withdrawn (b)(6)2018, after seeing the blister form and redness.The blisters/ redness lasted 2/3 weeks.The huge rectangle black mark/ discoloration was still there.Her dr was not sure if it would go away.She is to make an appointment with a dermatologist to see if the black discoloration and rectangle will go away.The outcome of the event chemical burn/huge black rectangle mark with open little blisters/2nd degree burn to lower back and skin discoloration was not recovered.She recovered from not feeling too well on an unspecified date.The outcome of back was itchy was unknown.The nurse further reported that the patient provided information to her regarding the reported adverse events with the use of the product.The nurse considered that there was a reasonable possibility that the event 2nd degree burn to lower back was related to thermacare heatwrap.Sample status was not requested.Product investigation summary results were as follows: initial complaint assessment: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: scope: date contacted: (b)(6)2015 through (b)(6)2018/manufacturing site: (site name)/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 258 complaints for lower back and hip products during this time period for the class/subclass.Of the 258 complaints; 29 complaints has the batch number recorded as "unknown".The 229 remaining complaints were evaluated.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse events safety request for investigation for lbh products.There is no further action required.Based on this pcom search for the subclass of adverse event safety request for investigation for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for lbh products, for adverse event lbh dec2015 - dec2018.The root cause category is non-assignable (complaint not confirmed).Our 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.No trend has been identified for lbh product for the subclass of adverse event safety request for investigation.On 19mar2020, product quality complaints provided the following additional investigation information: there was no reasonable suggestion of device malfunction.The sample status at the site was not received.Batch t48943 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.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 the wrap caused a "2nd degree burn on lower back and skin color darkening.' the cause of the wrap causing a burn and skin color darkening 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.Follow-up (08feb2019): new information reported from product quality complaints includes product investigation summary results.Follow up (15apr2019): new information received from a contactable nurse includes new reporter, patient data (age, weight, height), medical history, past drug data, new event (skin color darkening), onset of event, outcome of event, deny of hospitalization, treatment details, event details and causality assessment.Follow-up (06may2019): new information from a contactable consumer includes: product information (administration dates, details, action taken), concomitant medications (none), patient history, updated event information (event onset dates and new events: back was itchy, back was really red), additional treatment details, hospital admission status (none), and event outcome.Follow-up (17may2019): new information reported from product quality complaints includes product investigation summary results.Follow-up (01jul2019): follow-up attempts are completed.No further information is expected.Follow-up (19mar2020): new information received from a product quality complaint groups includes: additional investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event of burns second degree is described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events feeling abnormal, skin discolouration and pruritus are non-serious.The events are 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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
|
| |
|
Search Alerts/Recalls
|
|
|
