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| Lot Number S97473; S23841 |
| Device Problems
Nonstandard Device (1420); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Excessive Heating (4030)
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| Patient Problems
Inflammation (1932); Itching Sensation (1943); Partial thickness (Second Degree) Burn (2694)
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| Event Date 03/18/2019 |
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Event Type
Injury
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Event Description
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Burned skin, inflamed, burned leg/leg itching and hot, skin all jacked up, took skin where wrap was in 3 places on right side of left leg/took skin off, raw and hot; 3 open sores; 3 little scars [burns second degree].Read the usage instructions on thermacare before used the product/ not check skin under the product while wearing thermacare [intentional device misuse], she couldn't even stand it for 3 hours, since it got so hot [device issue], indication for use: knee pain/used it on the knee [device use issue].Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A (b)(6) female patient (non-pregnant ) started to receive thermacare heatwrap (thermacare lower back & hip), device lot number s97473, expiration date mar2020.From an unspecified date to mid of (b)(6) 2019 applied one wrap to skin once for 3 hours for knee pain.Medical history included ongoing bad knee and ongoing post-menopausal.The patient was currently under the care of a physician for bad knee.The patient classified her skin tone as very light or fair, the patient did not have sensitive skin or abnormal skin conditions.There were no concomitant medications.The patient previously took thermacare heatwraps for product used for unknown indication off and on for at least a year and experienced no adverse effect.The patient had not previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).The product was the thermacare back wrap.The color of the box she purchased was red box.The patient attached the adhesive to body.It was attached to her body for about three hours and she took it off before she went to sleep.The patient used thermacare back wrap on her knee for knee pain.She wrapped it around knee and it burned her leg.It burned the skin, it was inflamed, and she took the wrap off and it burned her leg.This was mid (b)(6) 2019, she had a picture, and had three little scars where it was in (b)(6) 2019.She couldn't go the whole 8 hours, since her leg was on fire, maybe 3 hours.She couldn't even stand it for 3 hours, since it got so hot, moreso than any thermacare product before, and it gave her a burn.She noticed something was wrong, over 3 hours, and her leg was itching and hot, so she took the wrap off and the skin was all jacked up, it took the skin where the wrap was in 3 places on the right side of the left leg, and it took the skin off, and it was raw and hot, and she wiped it off, and put an antibacterial cream on it.Then she got this thing that they called about the recall.The patient did not consult a healthcare professional for the symptoms.She didn't go to the doctor, she was just burned by it.She put antibacterial cream on it, on the 3 open sores.The patient did not engage in exercise while using the product (for example, running, bicycling); did read the usage instructions on thermacare before she used the product, but did not check her skin under the product while wearing thermacare.She started using it about a year ago, when she found about her knee issue, and it was probably a temporary stop, since she got a prescription item from the doctor for her knee.This single-use device that was not reprocessed and reused on a patient.The patient reported there was no permanent impairment/damage of a body structure/function (disability).She guessed there was malfunction, since she used them before and never had a problem, and this one was hotter than the others ever got.The patient considered there was a reasonable possibility that adverse event burn was related to the device.There was no investigation assessment.The device was available for evaluation.The packaging was sealed and intact.Action taken in response to events for thermacare heatwrap was device temporarily discontinued.The patient used antibacterial cream as treatment for event "burned the skin, it was inflamed, it burned her leg/leg was itching and hot, skin was all jacked up, it took the skin where the wrap was in 3 places on the right side of the left leg, and it took the skin off, and it was raw and hot; the 3 open sores; 3 little scars".The outcome of event "burned the skin, it was inflamed, it burned her leg/leg was itching and hot, skin was all jacked up, it took the skin where the wrap was in 3 places on the right side of the left leg, and it took the skin off, and it was raw and hot; the 3 open sores; 3 little scars" and of event "she couldn't even stand it for 3 hours, since it got so hot" was not recovered, and of the other 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 "burns second degree", "intentional device misuse" and "device issue" are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.Additional follow-up will be reported when the evaluation is completed.
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Event Description
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Event verbatim [preferred term] burned skin, inflamed, burned leg/leg itching and hot, skin all jacked up/took skin off, raw and hot;3 open sores; 4 scars/burned on my left knee in 4 spots/4 blister on my knee area [burns second degree] , read the usage instructions on thermacare before used the product/ not check skin under the product while wearing thermacare [intentional device misuse] , it got so hot/this one first got hotter than hot [device issue] , indication for use: knee pain/used it on the knee [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A 51-year-old female patient (non-pregnant) started to receive thermacare heatwrap (thermacare lower back & hip), device lot number s97473, expiration date mar2020, from 18mar2019 to mar2019 for 2 days applied one wrap to skin for keen pain.Medical history included ongoing bad knee and ongoing post-menopausal.The patient was currently under the care of a physician for bad knee.The patient classified her skin tone as very light or fair, the patient did not have sensitive skin or abnormal skin conditions.There were no concomitant medications.The patient previously took thermacare heatwraps for keen pain off and on from dec2018 and experienced no adverse effect.The patient had not previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).The product was the thermacare back wrap.The color of the box she purchased was red box.The patient attached the adhesive to body.It was attached to her body at 05:30 and she took it off at 6:30, not even 1 hr.The patient used thermacare back wrap on her knee for knee pain on (b)(6) 2019.She wrapped it around knee and it burned her leg.It burned the skin, it was inflamed, and she took the wrap off and it burned her leg.This was (b)(6)2019, she had a picture, and had three little scars where it was on (b)(6)2019.She couldn't go the whole 8 hours, since her leg was on fire.She couldn't even stand it, since it got so hot, moreso than any thermacare product before, and it gave her a burn.She noticed something was wrong, and her leg was itching and hot, so she took the wrap off and the skin was all jacked up, it took the skin where the wrap was in 3 places on the right side of the left leg, and it took the skin off, and it was raw and hot, and she wiped it off, and put an antibacterial cream on it.The patient further reported that she first put in at her knee.On (b)(6) 2019, she put it like all the other times but this one first got hotter than hot- took it off and her leg was red and it burned her skin she had 4 blister on her knee area.She got burned on her left knee in 4 spots.She took it off.She treated it at home.She just had 4 sears below left knee area.She had 4 scars from the product.No admission to hospital involved for burn.Then she got this thing that they called about the recall.The patient did not consult a healthcare professional for the symptoms.She didn't go to the doctor, she was just burned by it.She put antibacterial cream on it, on the 3 open sores.The patient did not engage in exercise while using the product (for example, running, bicycling); did read the usage instructions on thermacare before she used the product, but did not check her skin under the product while wearing thermacare on (b)(6) 2019.She started using it about a year ago, when she found about her knee issue, and it was probably a temporary stop, since she got a prescription item from the doctor for her knee.This single-use device that was not reprocessed and reused on a patient.The patient reported there was no permanent impairment/damage of a body structure/function (disability).She guessed there was malfunction, since she used them before and never had a problem, and this one was hotter than the others ever got.The patient considered there was a reasonable possibility that adverse event burn was related to the device.There was no investigation assessment.The device was available for evaluation.The packaging was sealed and intact.She sent product back in supplied envelope.There was no product remaining.Action taken in response to events for thermacare heatwrap was temporarily discontinued.The patient used antibacterial cream as treatment for event "burned skin, inflamed, burned leg/leg itching and hot, skin all jacked up/took skin off, raw and hot;3 open sores; 4 scars/burned on my left knee in 4 spots/4 blister on my knee area".The outcome of event "burned skin, inflamed, burned leg/leg itching and hot, skin all jacked up/took skin off, raw and hot;3 open sores; 4 scars/burned on my left knee in 4 spots/4 blister on my knee area" and of event "it got so hot/this one first got hotter than hot" was not recovered, and of the other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (b)(6) 2019): new information received from a contactable consumer includes past product data, device data (start date, stop date) and information, onset date of events, deny of hospitalization and additional event information (4 scars/burned on my left knee in 4 spots/4 blister on my knee area).Company clinical evaluation comment based on the information provided, the events "burns second degree", "intentional device misuse" and "device issue" are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device.Additional follow-up will be reported when the evaluation is completed., comment: based on the information provided, the events "burns second degree", "intentional device misuse" and "device issue" are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device.Additional follow-up will be reported when the evaluation is completed.
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Manufacturer Narrative
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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 quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.No trends were identified for the batch or the sub class of too hot.The returned sample has not been received at the site for evaluation.This batch was involved in investigation pr#; opened after an fda inspection to address not performing isolation after a cell with a high temperature was found during in process testing.The main root cause of the event is related to misunderstanding the corrective action procedure (cap) for investigating, retesting and isolating product with a high cell temperature.The root cause was identified as method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by area quality review team (aqrt) on april 11, 2019.The outcome of aqrt was to recall the batches with a high cell temperature.The final scope included the following lower back and hip batches: s00639, s23902, s97473 and w37940.
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Event Description
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Burned skin, inflamed, burned leg/leg itching and hot, skin all jacked up/took skin off, raw and hot; 3 open sores; 4 scars/burned on my left knee in 4 spots/4 blister on my knee area [burns second degree] , read the usage instructions on thermacare before used the product/ not check skin under the product while wearing thermacare [intentional device misuse] , it got so hot/this one first got hotter than hot [device issue] , indication for use: knee pain/used it on the knee [device use issue].Case narrative: this is a spontaneous report from a contactable consumer reporting for herself.A 51-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number s97473, expiration date mar2020) from (b)(6) 2019 for 2 days applied one wrap to skin for knee pain.Medical history included ongoing bad knee and ongoing post-menopausal.The patient was currently under the care of a physician for bad knee.The patient classified her skin tone as very light or fair, the patient did not have sensitive skin or abnormal skin conditions.There were no concomitant medications.The patient previously took thermacare heatwraps for knee pain off and on from (b)(6) 2018 and experienced no adverse effect.The patient had not previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).The color of the box she purchased was red box.The patient attached the adhesive to body.It was attached to her body at 5:30 and she took it off at 6:30, not even 1 hr.The patient used thermacare back wrap on her knee for knee pain on (b)(6) 2019.She wrapped it around knee and it burned her leg.It burned the skin, it was inflamed, and she took the wrap off and it burned her leg.This was (b)(6) 2019, she had a picture, and had three little scars.She couldn't go the whole 8 hours, since her leg was on fire.She couldn't even stand it, since it got so hot, more so than any thermacare product before, and it gave her a burn.She noticed something was wrong, and her leg was itching and hot, so she took the wrap off and the 'skin was all jacked up', it took the skin where the wrap was in 3 places on the right side of the left leg, and it took the skin off, and it was raw and hot, and she wiped it off, and put an antibacterial cream on it.The patient first put in at her knee.On (b)(6) 2019, she put it like all the other times but this one first got hotter than hot- took it off and her leg was red and it burned her skin she had 4 blister on her knee area.She got burned on her left knee in 4 spots.She treated it at home.She just had 4 sears below left knee area.She had 4 scars.No admission to hospital involved for burn.The patient did not consult a healthcare professional for the symptoms.The patient did not engage in exercise while using the product; did read the usage instructions before she used the product, but did not check her skin under the product while wearing it on (b)(6) 2019.She started using it about a year ago, when she found about her knee issue, and it was probably a temporary stop, since she got a prescription item from the doctor for her knee.The patient reported there was no permanent impairment/damage of a body structure/function (disability).She used them before and never had a problem, and this one was hotter than the others ever got.The patient considered there was a reasonable possibility that adverse event burn was related to the device.There was no investigation assessment.The device was available for evaluation.The packaging was sealed and intact.She sent product back in supplied envelope, and there was no product remaining.Action taken in response to events for thermacare heatwrap was temporarily discontinued.The patient used antibacterial cream as treatment for event "burned skin, inflamed, burned leg/leg itching and hot, skin all jacked up/took skin off, raw and hot; 3 open sores; 4 scars/burned on my left knee in 4 spots/4 blister on my knee area".The outcome of event "burned skin, inflamed, burned leg/leg itching and hot, skin all jacked up/took skin off, raw and hot; 3 open sores; 4 scars/burned on my left knee in 4 spots/4 blister on my knee area" and of event "it got so hot/this one first got hotter than hot" was not recovered, and of the other events was unknown.Per the product quality group, the severity ranking was reported as s3.The citi customizable search returned a total of 603 complaints.Seven complaints were related to batch s97473.None were confirmed to have a manufacturing process root cause for a complaint.The remaining recall batches were not reported.None of the complaints were identified as having a manufacturing related root cause.Seven complaints were related to batch s97473.None were confirmed to have a manufacturing process root cause.The remaining recall batches were not reported.Based on this citi customizable search, the trending chart shows an increase in adverse events (aes) for apr2019 and may2019 for the subclasses for lbh products.The majority of the complaints by description have a severity ranking of s1.The data did not show an increase over time (24 months).There is not a trend identified.The root cause category is non-assignable (complaint not confirmed).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 quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.No trends were identified for the batch or the sub class of too hot.The returned sample has not been received at the site for evaluation.This batch was involved in investigation pr#; opened after an fda inspection to address not performing isolation after a cell with a high temperature was found during in process testing.The main root cause of the event is related to misunderstanding the corrective action procedure (cap) for investigating, retesting and isolating product with a high cell temperature.The root cause was identified as method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by area quality review team (aqrt) on april 11, 2019.The outcome of aqrt was to recall the batches with a high cell temperature.The final scope included the following lower back and hip batches: s00639, s23902, s97473 and w37940.Follow-up (10jun2019): new information received from a contactable consumer includes past product data, device data (start date, stop date) and information, onset date of events, deny of hospitalization and additional event information (4 scars/burned on my left knee in 4 spots/4 blister on my knee area).Follow-up (29jul2019): new information received from the product quality complaint group includes: severity ranking.Follow-up (05sep2019): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (30aug2019): new information received from the product quality complaint group includes: investigation details.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment based on the information provided, the events "burns second degree", "intentional device misuse" and "device issue" are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are 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.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", "intentional device misuse" and "device issue" are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are 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.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] burned skin, inflamed, burned leg/leg itching and hot, skin all jacked up/took skin off, raw and hot;3 open sores; 4 scars/burned on my left knee in 4 spots/4 blister on my knee area [burns second degree] , read the usage instructions on thermacare before used the product/ not check skin under the product while wearing thermacare [intentional device misuse] , it got so hot/this one first got hotter than hot [device issue] , indication for use: knee pain/used it on the knee [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A 51-year-old female patient (non-pregnant) started to receive thermacare heatwrap (thermacare lower back & hip), device lot number s97473, expiration date mar2020, from 18mar2019 for 2 days applied one wrap to skin for keen pain.Medical history included ongoing bad knee and ongoing post-menopausal.The patient was currently under the care of a physician for bad knee.The patient classified her skin tone as very light or fair, the patient did not have sensitive skin or abnormal skin conditions.There were no concomitant medications.The patient previously took thermacare heatwraps for keen pain off and on from dec2018 and experienced no adverse effect.The patient had not previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).The product was the thermacare back wrap.The color of the box she purchased was red box.The patient attached the adhesive to body.It was attached to her body at 05:30 and she took it off at 6:30, not even 1 hr.The patient used thermacare back wrap on her knee for knee pain on 18mar2019.She wrapped it around knee and it burned her leg.It burned the skin, it was inflamed, and she took the wrap off and it burned her leg.This was 18mar2019, she had a picture, and had three little scars where it was on 18mar2019.She couldn't go the whole 8 hours, since her leg was on fire.She couldn't even stand it, since it got so hot, more so than any thermacare product before, and it gave her a burn.She noticed something was wrong, and her leg was itching and hot, so she took the wrap off and the skin was all jacked up, it took the skin where the wrap was in 3 places on the right side of the left leg, and it took the skin off, and it was raw and hot, and she wiped it off, and put an antibacterial cream on it.The patient further reported that she first put in at her knee.On 18mar2019, she put it like all the other times but this one first got hotter than hot- took it off and her leg was red and it burned her skin she had 4 blister on her knee area.She got burned on her left knee in 4 spots.She took it off.She treated it at home.She just had 4 sears below left knee area.She had 4 scars from the product.No admission to hospital involved for burn.Then she got this thing that they called about the recall.The patient did not consult a healthcare professional for the symptoms.She didn't go to the doctor, she was just burned by it.She put antibacterial cream on it, on the 3 open sores.The patient did not engage in exercise while using the product (for example, running, bicycling); did read the usage instructions on thermacare before she used the product, but did not check her skin under the product while wearing thermacare on 18mar2019.She started using it about a year ago, when she found about her knee issue, and it was probably a temporary stop, since she got a prescription item from the doctor for her knee.The patient reported there was no permanent impairment/damage of a body structure/function (disability).She guessed there was malfunction, since she used them before and never had a problem, and this one was hotter than the others ever got.The patient considered there was a reasonable possibility that adverse event burn was related to the device.There was no investigation assessment.The device was available for evaluation.The packaging was sealed and intact.She sent product back in supplied envelope.There was no product remaining.Per the product quality group, the severity ranking for reported as s3.Action taken in response to events for thermacare heatwrap was temporarily discontinued.The patient used antibacterial cream as treatment for event "burned skin, inflamed, burned leg/leg itching and hot, skin all jacked up/took skin off, raw and hot;3 open sores; 4 scars/burned on my left knee in 4 spots/4 blister on my knee area".The outcome of event "burned skin, inflamed, burned leg/leg itching and hot, skin all jacked up/took skin off, raw and hot;3 open sores; 4 scars/burned on my left knee in 4 spots/4 blister on my knee area" and of event "it got so hot/this one first got hotter than hot" was not recovered, and of the other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (10jun2019): new information received from a contactable consumer includes past product data, device data (start date, stop date) and information, onset date of events, deny of hospitalization and additional event information (4 scars/burned on my left knee in 4 spots/4 blister on my knee area).Follow-up (29jul2019): new information received from the product quality complaint group includes: severity ranking., comment: based on the information provided, the events "burns second degree", "intentional device misuse" and "device issue" are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device.Additional follow-up will be reported when the evaluation is completed.
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Event Description
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Event verbatim [preferred term] burned skin, inflamed, burned leg/leg itching and hot, skin all jacked up/took skin off, raw and hot;3 open sores; 4 scars/burned on my left knee in 4 spots/4 blister on my knee area [burns second degree] , read the usage instructions on thermacare before used the product/ not check skin under the product while wearing thermacare [intentional device misuse] , it got so hot/this one first got hotter than hot [device issue] , indication for use: knee pain/used it on the knee [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A 51-year-old female patient (non-pregnant) started to receive thermacare heatwrap (thermacare lower back & hip) (device lot number s97473, expiration date mar2020) from 18mar2019 for 2 days applied one wrap to skin for keen pain.Medical history included ongoing bad knee and ongoing post-menopausal.The patient was currently under the care of a physician for bad knee.The patient classified her skin tone as very light or fair, the patient did not have sensitive skin or abnormal skin conditions.There were no concomitant medications.The patient previously took thermacare heatwraps for keen pain off and on from (b)(6) 2018 and experienced no adverse effect.The patient had not previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).The product was the thermacare back wrap.The color of the box she purchased was red box.The patient attached the adhesive to body.It was attached to her body at 05:30 and she took it off at 6:30, not even 1 hr.The patient used thermacare back wrap on her knee for knee pain on (b)(6) 2019.She wrapped it around knee and it burned her leg.It burned the skin, it was inflamed, and she took the wrap off and it burned her leg.This was 18mar2019, she had a picture, and had three little scars where it was on (b)(6) 2019.She couldn't go the whole 8 hours, since her leg was on fire.She couldn't even stand it, since it got so hot, more so than any thermacare product before, and it gave her a burn.She noticed something was wrong, and her leg was itching and hot, so she took the wrap off and the skin was all jacked up, it took the skin where the wrap was in 3 places on the right side of the left leg, and it took the skin off, and it was raw and hot, and she wiped it off, and put an antibacterial cream on it.The patient further reported that she first put in at her knee.On (b)(6) 2019, she put it like all the other times but this one first got hotter than hot- took it off and her leg was red and it burned her skin she had 4 blister on her knee area.She got burned on her left knee in 4 spots.She took it off.She treated it at home.She just had 4 sears below left knee area.She had 4 scars from the product.No admission to hospital involved for burn.Then she got this thing that they called about the recall.The patient did not consult a healthcare professional for the symptoms.She didn't go to the doctor, she was just burned by it.She put antibacterial cream on it, on the 3 open sores.The patient did not engage in exercise while using the product (for example, running, bicycling); did read the usage instructions on thermacare before she used the product, but did not check her skin under the product while wearing thermacare on (b)(6) 2019.She started using it about a year ago, when she found about her knee issue, and it was probably a temporary stop, since she got a prescription item from the doctor for her knee.The patient reported there was no permanent impairment/damage of a body structure/function (disability).She guessed there was malfunction, since she used them before and never had a problem, and this one was hotter than the others ever got.The patient considered there was a reasonable possibility that adverse event burn was related to the device.There was no investigation assessment.The device was available for evaluation.The packaging was sealed and intact.She sent product back in supplied envelope.There was no product remaining.Action taken in response to events for thermacare heatwrap was temporarily discontinued.The patient used antibacterial cream as treatment for event "burned skin, inflamed, burned leg/leg itching and hot, skin all jacked up/took skin off, raw and hot;3 open sores; 4 scars/burned on my left knee in 4 spots/4 blister on my knee area".The outcome of event "burned skin, inflamed, burned leg/leg itching and hot, skin all jacked up/took skin off, raw and hot;3 open sores; 4 scars/burned on my left knee in 4 spots/4 blister on my knee area" and of event "it got so hot/this one first got hotter than hot" was not recovered, and of the other events was unknown.Per the product quality group, the severity ranking was reported as s3.Additional information received from product quality complaint (pqc) group included investigation results.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 quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.No trends were identified for the batch or the sub class of too hot.The returned sample has not been received at the site for evaluation.This batch was involved in investigation pr#; opened after an fda inspection to address not performing isolation after a cell with a high temperature was found during in process testing.The main root cause of the event is related to misunderstanding the corrective action procedure (cap) for investigating, retesting and isolating product with a high cell temperature.The root cause was identified as method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by area quality review team (aqrt) on april 11, 2019.The outcome of aqrt was to recall the batches with a high cell temperature.The final scope included the following lower back and hip batches: s00639, s23902, s97473 and w37940.Additional information has been requested and will be provided as it becomes available.Follow-up (10jun2019): new information received from a contactable consumer includes past product data, device data (start date, stop date) and information, onset date of events, deny of hospitalization and additional event information (4 scars/burned on my left knee in 4 spots/4 blister on my knee area).Follow-up (29jul2019): new information received from the product quality complaint group includes: severity ranking.Follow-up (05sep2019): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment based on the information provided, the events "burns second degree", "intentional device misuse" and "device issue" are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are 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.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", "intentional device misuse" and "device issue" are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are 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.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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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 quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.No trends were identified for the batch or the sub class of too hot.The returned sample has not been received at the site for evaluation.This batch was involved in investigation pr#; opened after an fda inspection to address not performing isolation after a cell with a high temperature was found during in process testing.The main root cause of the event is related to misunderstanding the corrective action procedure (cap) for investigating, retesting and isolating product with a high cell temperature.The root cause was identified as method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by area quality review team (aqrt) on april 11, 2019.The outcome of aqrt was to recall the batches with a high cell temperature.The final scope included the following lower back and hip batches: s00639, s23902, s97473 and w37940.
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Event Description
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Event verbatim [preferred term].Burned skin, inflamed, burned leg/leg itching and hot, skin all jacked up/took skin off, raw and hot;3 open sores; 4 scars/burned on my left knee in 4 spots/4 blister on my knee area [burns second degree].Read the usage instructions on thermacare before used the product/ not check skin under the product while wearing thermacare [intentional device misuse].It got so hot/this one first got hotter than hot [device issue].Indication for use: knee pain/used it on the knee [device use issue].Narrative: this is a spontaneous report from a contactable consumer reporting for herself.A 51-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number s97473, expiration date mar2020) from (b)(6) 2019 for 2 days applied one wrap to skin for knee pain.Additional lot# s23841 and expiry may2020 provided by product complaints.Medical history included ongoing bad knee and ongoing post-menopausal.The patient was currently under the care of a physician for bad knee.The patient classified her skin tone as very light or fair, the patient did not have sensitive skin or abnormal skin conditions.There were no concomitant medications.The patient previously took thermacare heatwraps for knee pain off and on from (b)(6) 2018 and experienced no adverse effect.The patient had not previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).The color of the box she purchased was red box.The patient attached the adhesive to body.It was attached to her body at 5:30 and she took it off at 6:30, not even 1 hr.The patient used thermacare back wrap on her knee for knee pain on (b)(6) 2019.She wrapped it around knee and it burned her leg.It burned the skin, it was inflamed, and she took the wrap off and it burned her leg.This was (b)(6) 2019, she had a picture, and had three little scars.She couldn't go the whole 8 hours, since her leg was on fire.She couldn't even stand it, since it got so hot, more so than any thermacare product before, and it gave her a burn.She noticed something was wrong, and her leg was itching and hot, so she took the wrap off and the 'skin was all jacked up', it took the skin where the wrap was in 3 places on the right side of the left leg, and it took the skin off, and it was raw and hot, and she wiped it off, and put an antibacterial cream on it.The patient first put in at her knee.On (b)(6) 2019, she put it like all the other times but this one first got hotter than hot- took it off and her leg was red and it burned her skin she had 4 blister on her knee area.She got burned on her left knee in 4 spots.She treated it at home.She just had 4 sears below left knee area.She had 4 scars.No admission to hospital involved for burn.The patient did not consult a healthcare professional for the symptoms.The patient did not engage in exercise while using the product; did read the usage instructions before she used the product, but did not check her skin under the product while wearing it on (b)(6) 2019.She started using it about a year ago, when she found about her knee issue, and it was probably a temporary stop, since she got a prescription item from the doctor for her knee.The patient reported there was no permanent impairment/damage of a body structure/function (disability).She used them before and never had a problem, and this one was hotter than the others ever got.The patient considered there was a reasonable possibility that adverse event burn was related to the device.There was no investigation assessment.The device was available for evaluation.The packaging was sealed and intact.She sent product back in supplied envelope, and there was no product remaining.Action taken in response to events for thermacare heatwrap was temporarily discontinued.The patient used antibacterial cream as treatment for event "burned skin, inflamed, burned leg/leg itching and hot, skin all jacked up/took skin off, raw and hot;3 open sores; 4 scars/burned on my left knee in 4 spots/4 blister on my knee area".The outcome of event "burned skin, inflamed, burned leg/leg itching and hot, skin all jacked up/took skin off, raw and hot;3 open sores; 4 scars/burned on my left knee in 4 spots/4 blister on my knee area" and of event "it got so hot/this one first got hotter than hot" was not recovered, and of the other events was unknown.Per the product quality group, the severity ranking was reported as s3.The citi customizable search returned a total of (b)(4) complaints.(b)(4)complaints were related to batch s97473.None were confirmed to have a manufacturing process root cause for a complaint.The remaining recall batches were not reported.None of the complaints were identified as having a manufacturing related root cause.(b)(4) complaints were related to batch s97473.None were confirmed to have a manufacturing process root cause.The remaining recall batches were not reported.Based on this citi customizable search, the trending chart shows an increase in adverse events (aes) for (b)(6) 2019 for the subclasses for lbh products.The majority of the complaints by description have a severity ranking of s1.The data did not show an increase over time (24 months).There is not a trend identified.The root cause category is non-assignable (complaint not confirmed).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 quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.No trends were identified for the batch or the sub class of too hot.The returned sample has not been received at the site for evaluation.This batch was involved in investigation pr#; opened after an fda inspection to address not performing isolation after a cell with a high temperature was found during in process testing.The main root cause of the event is related to misunderstanding the corrective action procedure (cap) for investigating, retesting and isolating product with a high cell temperature.The root cause was identified as method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by area quality review team (aqrt) on (b)(6) 2019.The outcome of aqrt was to recall the batches with a high cell temperature.The final scope included the following lower back and hip batches: s00639, s23902, s97473 and w37940.Additional information received from product quality complaints for lot # s23841 (investigation results for subclass: wrap/patch/pad too hot and complaint sample evaluation): site sample status: received at the site.Date samples were received (gmt): 29may2019.Visual compl smpl eval cmpletd (gmt): 30may2019.Return sample evaluation: 2 wraps - wraps are inside sealed pouches.Opened pouches to inspect wraps - no obvious defects.One non-thermacare wrap, 2 pouches - (l) s23841 06/07, exp may2020 09:17, pouches are sealed no obvious defects, 1 carton - coded flap from carton, (l) s23841 06/07.Batch s23841 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.Our manufacturing operations employ quality control procedures which include statistical sampling and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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 (10jun2019): new information received from a contactable consumer includes past product data, device data (start date, stop date) and information, onset date of events, deny of hospitalization and additional event information (4 scars/burned on my left knee in 4 spots/4 blister on my knee area).Follow-up (29jul2019): new information received from the product quality complaint group includes: severity ranking.Follow-up (05sep2019): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (30aug2019): new information received from the product quality complaint group includes: investigation details.Follow-up attempts are completed.No further information is expected.Follow-up (23sep2019): new information from a product quality complaint group includes investigation results for lot # s23841/ expiry may2020.No follow up attempts needed.No further information is expected., comment: based on the information provided, the events "burns second degree", "intentional device misuse" and "device issue" are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are 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.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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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 quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.No trends were identified for the batch or the sub class of too hot.The returned sample has not been received at the site for evaluation.This batch was involved in investigation pr#; opened after an fda inspection to address not performing isolation after a cell with a high temperature was found during in process testing.The main root cause of the event is related to misunderstanding the corrective action procedure (cap) for investigating, retesting and isolating product with a high cell temperature.The root cause was identified as method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by area quality review team (aqrt) on april 11, 2019.The outcome of aqrt was to recall the batches with a high cell temperature.The final scope included the following lower back and hip batches: s00639, s23902, s97473 and w37940.Site sample status: received at the site.Date samples were received (gmt): 29may2019.Visual compl smpl eval cmpletd (gmt): 30may2019.Return sample evaluation: 2 wraps - wraps are inside sealed pouches.Opened pouches to inspect wraps - no obvious defects.One non-thermacare wrap, 2 pouches - (l) s23841 06/07, exp may2020 09:17, pouches are sealed no obvious defects, 1 carton - coded flap from carton, (l) s23841 06/07.Batch s23841 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.Our manufacturing operations employ quality control procedures which include statistical sampling and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.
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Search Alerts/Recalls
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