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| Lot Number L13066 |
| Device Problems
Burst Container or Vessel (1074); Improper or Incorrect Procedure or Method (2017)
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| Patient Problems
Pain (1994); Burning Sensation (2146); Rupture (2208); Complaint, Ill-Defined (2331); Partial thickness (Second Degree) Burn (2694)
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| Event Date 01/17/2016 |
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Event Type
Injury
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Event Description
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Burned her neck really, really bad, blister on her neck, looked like water blister [burns second degree].The blister popped [blister rupture].Had a really bad burning sensation [burning sensation].She had not checked under the patch during use [intentional device misuse].Little bubbles in the patch burst [product quality issue].Case description: this is a spontaneous report from a contactable consumer or other non hcp.An other ethnic group female patient of an unspecified age started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) (device lot number: l1303066, expiration date: may2018) from an unspecified date for neck pain.Medical history included scleroderma from an unknown date and unknown if ongoing, fibromyalgia from an unknown date and unknown if ongoing, thyroid problems from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, post shingles pain (had shingles 7 times) from an unknown date and unknown if ongoing, pneumonia from an unknown date and unknown if ongoing and physically disabled from an unknown date and unknown if ongoing.Concomitant medication included cyclobenzaprine hydrochloride (flexeril) from an unspecified date at 10mg as needed for pain, lisinopril (lisinopril) from an unspecified date at 20mg 2 times daily for hypertension and an unspecified thyroid medication.The patient previously took flexeril /(b)(4)/ for pain and experienced drug effect incomplete.On (b)(6) 2016, the patient reported she used one of the patches for approximately 4 hours and one of the little bubbles in the patch burst and it burned her neck really, really bad.She stated the contents of the heatwrap dripped down her back and when it did it was really cold for the first eruptions.The patient mentioned she had to throw out the patch because it pained her so bad and it got really bad.She reported after the bubble burst she had a really bad burning sensation.The patient removed the patch after the bubble ruptured and it was stinging and burning so bad.When she took it off, it was almost like a hole in the lower part of her neck, not right up in the neck.She added where it ruptured and dripped down there was like a water blister.It popped and when it popped it looked like a really bad burn and it is really, really painful.The patient mentioned she had not checked under the patch during use because she did not have any feelings until it ruptured.The patient assessed her skin tone as light.She stated she had sensitive skin as a result of the scleroderma.The patient reported she did not use the heatwrap over night or while sleeping.She did not wear several layers of clothing over the heatwrap and did not try to attach any adhesives to the product.The patient did not exercise while using the heatwrap and read the instructions prior to using the heatwrap.Action taken with the suspect product was unknown.Therapeutic measures taken included polysporin.Clinical outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of burn blister, blister popped and burning sensation as a result of the reported device misuse and product complaint as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events of burn blister, blister popped and burning sensation as a result of the reported device misuse and product complaint as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.
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Event Description
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Burned her neck really, really bad, blister on her neck, looked like water.Blister/ second degree burns on her neck and top of shoulder [burns second degree].The blister popped [blister rupture].Had a really bad burning sensation [burning sensation].She had not checked under the patch during use [intentional device misuse].Little bubbles in the patch burst [product quality issue].Skin was dark [skin discolouration].Chemical burn [chemical injury].Case description: this is a spontaneous report from a contactable consumer and the patient's husband.A (b)(6) caucasian female patient of an unspecified age started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) (device lot number: l1303066 (also reported as l13066), expiration date: may2018) from (b)(6) 2016, one wrap for neck pain, muscle relaxation, and tightness in neck and shoulders.Medical history included scleroderma from an unknown date 4 or 5 years ago, ongoing, fibromyalgia diagnosed 4 or 5 years ago ongoing, thyroid problems/thyroid disease from an unknown date ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, post shingles pain (had shingles 7 times) from an unknown date and unknown if ongoing, pneumonia from an unknown date and unknown if ongoing, physically disabled from an unknown date and unknown if ongoing, neuropathy from 4 or 5 years ago, ongoing, indigestion ongoing, arthritis ongoing, post-menopausal.Concomitant medication included cyclobenzaprine hydrochloride (flexeril) from an unspecified date at 10mg as needed for pain, lisinopril (lisinopril) from an unspecified date at 20mg 2 times daily for hypertension and an unspecified thyroid medication.The patient previously took flexeril /00428402/ for pain and experienced drug effect incomplete.On (b)(6) 2016, the patient reported she used one of the patches for approximately 3 hours and one of the little bubbles in the patch burst and it burned her neck really, really bad and the top part of her shoulder.She stated the contents of the heatwrap dripped down her back and when it did it was really cold for the first eruptions.The patient mentioned she had to throw out the patch because it pained her so bad and it got really bad.She reported after the bubble burst she had a really bad burning sensation.The patient removed the patch after the bubble ruptured and it was stinging and burning so bad.When she removed the wrap the skin was dark and blistered up (the size of a silver dollar) really bad then tapered off to another little small place a half an inch on the side of her neck like it ran down.When she took it off, it was almost like a hole in the lower part of her neck, not right up in the neck.She added where it ruptured and dripped down there was like a water blister.It popped and when it popped it looked like a really bad burn and it is really, really painful.On (b)(6) 2016 she went to the emergency room and was told it was a chemical burn.Three doctors there had never seen it before and came into her room to see it.She was treated with silvadene burn cream and was referred to a burn clinic.They also gave her pain medication.She was told even if the blister ruptures, the chemical will continue to burn until it burns out.On (b)(6) 2016 she saw her primary physician and was told the burn would most likely cause permanent nerve damage, but that may not be confirmed until later.The patient's husband was concerned his wife will have a bad scar for the rest of her life that may prevent her from wearing the types of clothing she likes to wear, like sundresses with the back out.The patient's husband reported it is very painful for his wife.He has never seen his wife have pain like this.He feels she should not have to suffer like this.The patient mentioned she had not checked under the patch during use because she did not have any feelings until it ruptured.The patient assessed her skin tone as light or fair.She stated she had sensitive skin as a result of the scleroderma.The patient reported she did not use the heatwrap over night or while sleeping.She did not wear several layers of clothing over the heatwrap and did not try to attach any adhesives to the product.She did attach the adhesive to body.The patient did not exercise while using the heatwrap and read the instructions prior to using the heatwrap.It was reported there is no product remaining, only the box and wrapper, the product itself was discarded.The patient did not previously use thermacare.The patient did not previously use any other heat products for pain relief.She wore sitting in the recliner looking at tv, wearing pajamas.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included polysporin, silvadene burn cream, and pain medication.Clinical outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2016): new information received from a contactable consumer on behalf of his wife included: patient data (age), relevant medical history, product data (additional lot #, start/stop dates, additional indications and action taken), reaction data (additional events of chemical burn, skin was dark and onset date of events) and additional treatment for the events.Company clinical evaluation comment: based on the information provided, the events of burn blister, blister popped, burning sensation, chemical burn and dark skin as a result of the reported device misuse and product complaint as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets follow-up 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events of burn blister, blister popped, burning sensation, chemical burn and dark skin as a result of the reported device misuse and product complaint as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets follow-up 10-day eu and 30-day fda reportability.
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Manufacturer Narrative
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The plant has reviewed this batch from a manufacturing and technical
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.After a review of the batch thermal records, wrap thermal results all met
product release criteria.Consumer alleges burn from wrap.The cause of the
alleged burn is inconclusive since review of records does not provide
evidence to support defective product.The product effect may vary with each
individual.
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Event Description
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Case description: this is a spontaneous report from a contactable consumer and the patient's husband.A (b)(6)-year-old caucasian female patient started to use thermacare heatwrap (thermacare muscle & joint) (device lot number: l13066, expiration date: may2018) from (b)(6) 2016, one wrap for neck pain, muscle spasm, and tightness in neck and shoulders.Medical history included scleroderma from an unknown date 4 or 5 years ago, ongoing, fibromyalgia diagnosed 4 or 5 years ago ongoing, thyroid problems/thyroid disease from an unknown date ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, post shingles pain (had shingles 7 times) from an unknown date and unknown if ongoing, pneumonia from an unknown date and unknown if ongoing, physically disabled from an unknown date and unknown if ongoing, neuropathy from 4 or 5 years ago, ongoing, indigestion ongoing, arthritis ongoing, post-menopausal.Concomitant medication included cyclobenzaprine hydrochloride (flexeril) from an unspecified date at 10mg as needed for pain, lisinopril (lisinopril) from an unspecified date at 20mg 2 times daily for hypertension and an unspecified thyroid medication.The patient previously took flexeril for pain and experienced drug effect incomplete.On (b)(6) 2016, the patient reported she used one of the patches for approximately 3 hours and one of the little bubbles in the patch burst and it burned her neck really, really bad and the top part of her shoulder.She stated the contents of the heatwrap dripped down her back and when it did it was really cold for the first eruptions.The patient mentioned she had to throw out the patch because it pained her so bad and it got really bad.She reported after the bubble burst she had a really bad burning sensation.The patient removed the patch after the bubble ruptured and it was stinging and burning so bad.When she removed the wrap the skin was dark and blistered up (the size of a silver dollar) really bad then tapered off to another little small place a half an inch on the side of her neck like it ran down.When she took it off, it was almost like a hole in the lower part of her neck, not right up in the neck.She added where it ruptured and dripped down there was like a water blister.It popped and when it popped it looked like a really bad burn and it is really, really painful.On (b)(6) 2016 she went to the emergency room and was told it was a chemical burn.She was treated with silvadene burn cream and was referred to a burn clinic.They also gave her pain medication.She was told even if the blister ruptures, the chemical will continue to burn until it burns out.On (b)(6) 2016 she saw her primary physician and was told the burn would most likely cause permanent nerve damage, but that may not be confirmed until later.The patient's husband was concerned his wife will have a bad scar for the rest of her life that may prevent her from wearing the types of clothing she likes to wear, like sundresses with the back out.The patient's husband reported it is very painful for his wife.He has never seen his wife have pain like this.He feels she should not have to suffer like this.The patient mentioned she had not checked under the patch during use because she did not have any feelings until it ruptured.The patient assessed her skin tone as light or fair.She stated she had sensitive skin as a result of the scleroderma.The patient reported she did not use the heatwrap over night or while sleeping.She did not wear several layers of clothing over the heatwrap and did not try to attach any adhesives to the product.She did attach the adhesive to body.The patient did not exercise while using the heatwrap and read the instructions prior to using the heatwrap.It was reported there is no product remaining, only the box and wrapper, the product itself was discarded.The patient did not previously use thermacare.The patient did not previously use any other heat products for pain relief.She wore sitting in the recliner looking at tv, wearing pajamas.Upon follow-up received on 10feb2016, the patient reported when she had first applied the product, she could feel a little crawling sensation on her left shoulder and down her back.She stated the burns were not getting any better but had actually gotten worse, elaborated as the wound had become infected.The patient reported her hospital paper work stated her diagnosis was burned back, second degree, initial and another doctor she spoke to in the emergency department stated she had third degree burns, too.She stated she wore the heatwrap over the top of her t- shirt she had on, because that was what the instructions said to do.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included polysporin, silvadene burn cream, and pain medication.Clinical outcome of the events was not resolved.New information received from product quality complaint (pqc) group includes investigation results.The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, wrap thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (27jan2016): new information received from a contactable consumer on behalf of his wife included: patient data (age), relevant medical history, product data (additional lot #, start/stop dates, additional indications and action taken), reaction data (additional events of chemical burn, skin was dark and onset date of events) and additional treatment for the events.Follow-up (10feb2016): new information received from a contactable consumer includes: added suspect product indication and reaction data (additional events of 3rd degree burns, infection and formication).Follow-up (18mar2016): new information received from product quality complaints (pqc) group included: updated suspect product, updated suspect product lot number and provided product quality investigation results.Company clinical evaluation comment: based on the information provided, the events of burns third degree, burn blister, blister popped, burning sensation, infection, chemical burn and dark skin as a result of the reported device misuse and product complaint as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event formication is assessed as associated with the device use.This case meets (b)(6) and 30-day fda reportability.Case comment: based on the information provided, the events of burns third degree, burn blister, blister popped, burning sensation, infection, chemical burn and dark skin as a result of the reported device misuse and product complaint as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event formication is assessed as associated with the device use.This case meets final (b)(6) 30-day fda reportability.Evaluation summary the plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, wrap thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.
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Event Description
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She had got 3rd degree burns too [burns third degree].Blister on her neck, looked like water blister, second degree burns on her neck and top of shoulder [burns second degree].The blister popped [blister rupture].Had a really bad burning sensation/ burn that she got/ diagnosis was burned back/ second degree [burning sensation].She had not checked under the patch during use [intentional device misuse].Little bubbles in the patch burst [product quality issue].Skin was dark [skin discolouration].Chemical burn [chemical injury].Had become infected [infection].Could feel a little crawling sensation on her left shoulder and down her back [formication].Case description: this is a spontaneous report from a contactable consumer and the patient's husband.A (b)(6)-year-old caucasian female patient started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) (device lot number: l1303066 (also reported as l13066), expiration date: may2018) from (b)(6) 2016, one wrap for neck pain, muscle spasm, and tightness in neck and shoulders.Medical history included scleroderma from an unknown date 4 or 5 years ago, ongoing, fibromyalgia diagnosed 4 or 5 years ago ongoing, thyroid problems/thyroid disease from an unknown date ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, post shingles pain (had shingles 7 times) from an unknown date and unknown if ongoing, pneumonia from an unknown date and unknown if ongoing, physically disabled from an unknown date and unknown if ongoing, neuropathy from 4 or 5 years ago, ongoing, indigestion ongoing, arthritis ongoing, post-menopausal.Concomitant medication included cyclobenzaprine hydrochloride (flexeril) from an unspecified date at 10mg as needed for pain, lisinopril (lisinopril) from an unspecified date at 20mg 2 times daily for hypertension and an unspecified thyroid medication.The patient previously took flexeril for pain and experienced drug effect incomplete.On (b)(6) 2016, the patient reported she used one of the patches for approximately 3 hours and one of the little bubbles in the patch burst and it burned her neck really, really bad and the top part of her shoulder.She stated the contents of the heatwrap dripped down her back and when it did it was really cold for the first eruptions.The patient mentioned she had to throw out the patch because it pained her so bad and it got really bad.She reported after the bubble burst she had a really bad burning sensation.The patient removed the patch after the bubble ruptured and it was stinging and burning so bad.When she removed the wrap the skin was dark and blistered up (the size of a silver dollar) really bad then tapered off to another little small place a half an inch on the side of her neck like it ran down.When she took it off, it was almost like a hole in the lower part of her neck, not right up in the neck.She added where it ruptured and dripped down there was like a water blister.It popped and when it popped it looked like a really bad burn and it is really, really painful.On (b)(6) 2016 she went to the emergency room and was told it was a chemical burn.She was treated with silvadene burn cream and was referred to a burn clinic.They also gave her pain medication.She was told even if the blister ruptures, the chemical will continue to burn until it burns out.On (b)(6) 2016 she saw her primary physician and was told the burn would most likely cause permanent nerve damage, but that may not be confirmed until later.The patient's husband was concerned his wife will have a bad scar for the rest of her life that may prevent her from wearing the types of clothing she likes to wear, like sundresses with the back out.The patient's husband reported it is very painful for his wife.He has never seen his wife have pain like this.He feels she should not have to suffer like this.The patient mentioned she had not checked under the patch during use because she did not have any feelings until it ruptured.The patient assessed her skin tone as light or fair.She stated she had sensitive skin as a result of the scleroderma.The patient reported she did not use the heatwrap over night or while sleeping.She did not wear several layers of clothing over the heatwrap and did not try to attach any adhesives to the product.She did attach the adhesive to body.The patient did not exercise while using the heatwrap and read the instructions prior to using the heatwrap.It was reported there is no product remaining, only the box and wrapper, the product itself was discarded.The patient did not previously use thermacare.The patient did not previously use any other heat products for pain relief.She wore sitting in the recliner looking at tv, wearing pajamas.Upon follow-up received on 10feb2016, the patient reported when she had first applied the product, she could feel a little crawling sensation on her left shoulder and down her back.She stated the burns were not getting any better but had actually gotten worse, elaborated as the wound had become infected.The patient reported her hospital paper work stated her diagnosis was burned back, second degree, initial and another doctor she spoke to in the emergency department stated she had third degree burns, too.She stated she wore the heatwrap over the top of her t- shirt she had on, because that was what the instructions said to do.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included polysporin, silvadene burn cream, and pain medication.Clinical outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (27jan2016): new information received from a contactable consumer on behalf of his wife included: patient data (age), relevant medical history, product data (additional lot #, start/stop dates, additional indications and action taken), reaction data (additional events of chemical burn, skin was dark and onset date of events) and additional treatment for the events.Follow-up (10feb2016): new information received from a contactable consumer includes: added suspect product indication and reaction data (additional events of 3rd degree burns, infection and formication).Company clinical evaluation comment: based on the information provided, the events of burns third degree, burn blister, blister popped, burning sensation, infection, chemical burn and dark skin as a result of the reported device misuse and product complaint as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event formication is assessed as associated with the device use.This case meets follow-up (b)(6) and 30-day fda reportability.Case comment: based on the information provided, the events of burns third degree, burn blister, blister popped, burning sensation, infection, chemical burn and dark skin as a result of the reported device misuse and product complaint as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event formication is assessed as associated with the device use.This case meets follow-up (b)(6) and 30-day fda reportability.
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Event Description
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She had got 3rd degree burns too [burns third degree].Blister on her neck, looked like water blister, second degree burns on her neck and top of shoulder [burns second degree].Had a really bad burning sensation/ burn that she got/ diagnosis was burned back/ second degree [burning sensation].The blister popped [blister rupture].She had not checked under the patch during use [intentional device misuse].Little bubbles in the patch burst [product quality issue].Skin was dark [skin discolouration].Chemical burn [chemical injury].Had become infected [infection].Could feel a little crawling sensation on her left shoulder and down her back [formication].Case description: this is a spontaneous report from a contactable consumer and the patient's husband.A (b)(6)-year-old, caucasian female patient started to use thermacare heatwrap (thermacare muscle & joint) (device lot number: l13066, expiration date: may2018) from (b)(6) 2016, one wrap for neck pain, muscle spasm, and tightness in neck and shoulders.Medical history included scleroderma from an unknown date 4 or 5 years ago, ongoing, fibromyalgia diagnosed 4 or 5 years ago ongoing, thyroid problems/thyroid disease from an unknown date ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, post shingles pain (had shingles 7 times) from an unknown date and unknown if ongoing, pneumonia from an unknown date and unknown if ongoing, physically disabled from an unknown date and unknown if ongoing, neuropathy from 4 or 5 years ago, ongoing, indigestion ongoing, arthritis ongoing, post-menopausal.Concomitant medication included cyclobenzaprine hydrochloride (flexeril) from an unspecified date at 10mg as needed for pain, lisinopril (lisinopril) from an unspecified date at 20mg 2 times daily for hypertension and an unspecified thyroid medication.The patient previously took flexeril for pain and experienced "got some help with it".On (b)(6) 2016, the patient reported she used one of the patches for approximately 3 hours and one of the little bubbles in the patch burst and it burned her neck really, really bad and the top part of her shoulder.She stated the contents of the heatwrap dripped down her back and when it did it was really cold for the first eruptions.The patient mentioned she had to throw out the patch because it pained her so bad and it got really bad.She reported after the bubble burst she had a really bad burning sensation.The patient removed the patch after the bubble ruptured and it was stinging and burning so bad.When she removed the wrap the skin was dark and blistered up (the size of a silver dollar) really bad then tapered off to another little small place a half an inch on the side of her neck like it ran down.When she took it off, it was almost like a hole in the lower part of her neck, not right up in the neck.She added where it ruptured and dripped down there was like a water blister.It popped and when it popped it looked like a really bad burn and it is really, really painful.On (b)(6) 2016 she went to the emergency room and was told it was a chemical burn.She was treated with silvadene burn cream and was referred to a burn clinic.They also gave her pain medication.She was told even if the blister ruptures, the chemical will continue to burn until it burns out.On (b)(6) 2016 she saw her primary physician and was told the burn would most likely cause permanent nerve damage, but that may not be confirmed until later.The patient's husband was concerned his wife will have a bad scar for the rest of her life that may prevent her from wearing the types of clothing she likes to wear, like sundresses with the back out.The patient's husband reported it is very painful for his wife.He has never seen his wife have pain like this.He feels she should not have to suffer like this.The patient mentioned she had not checked under the patch during use because she did not have any feelings until it ruptured.The patient assessed her skin tone as light or fair.She stated she had sensitive skin as a result of the scleroderma.The patient reported she did not use the heatwrap over night or while sleeping.She did not wear several layers of clothing over the heatwrap and did not try to attach any adhesives to the product.She did attach the adhesive to body.The patient did not exercise while using the heatwrap and read the instructions prior to using the heatwrap.It was reported there is no product remaining, only the box and wrapper, the product itself was discarded.The patient did not previously use thermacare.The patient did not previously use any other heat products for pain relief.She wore sitting in the recliner looking at tv, wearing pajamas.Upon follow-up received on (b)(6) 2016, the patient reported when she had first applied the product, she could feel a little crawling sensation on her left shoulder and down her back.She stated the burns were not getting any better but had actually gotten worse, elaborated as the wound had become infected.The patient reported her hospital paper work stated her diagnosis was burned back, second degree, initial and another doctor she spoke to in the emergency department stated she had third degree burns, too.She stated she wore the heatwrap over the top of her t- shirt she had on, because that was what the instructions said to do.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included polysporin, silvadene burn cream, and pain medication.Clinical outcome of the events was not resolved.New information received from product quality complaint (pqc) group includes investigation results.The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, wrap thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (27jan2016): new information received from a contactable consumer on behalf of his wife included: patient data (age), relevant medical history, product data (additional lot #, start/stop dates, additional indications and action taken), reaction data (additional events of chemical burn, skin was dark and onset date of events) and additional treatment for the events.Follow-up (10feb2016): new information received from a contactable consumer includes: added suspect product indication and reaction data (additional events of 3rd degree burns, infection and formication).Follow-up (18mar2016): new information received from product quality complaints (pqc) group included: updated suspect product, updated suspect product lot number and provided product quality investigation results.Follow-up (08-apr-2016): follow-up attempts are completed.No further information is expected.Follow-up (22aug2016): this contactable consumer reported by way of medical records.This (b)(6)-year-old female patient applied thermacare heatwrap (thermacare muscle & joint) patch on (b)(6) 2016 on her upper back for neck and back pain and again on (b)(6) 2016 to alleviate pain.Her social history was significant for nicotine dependence and cigarette smoking (0.50 (half) pack per day and alternately reported as 1 pack per day) on an unknown date.Her family history was significant for alzheimer's disease (mother) and parkinson's disease (father) on an unknown date.Her past drug history included morphine allergy which caused nausea, cephalexin (keflex) and penicillin that caused rash on an unknown date.On (b)(6)2016, she fell asleep and rested for a while after applying patch.On the same day, she awoke to a burning sensation, to find the patch had ruptured and burned her skin.She was taken to the emergency room on (b)(6) 2016 where she was diagnosed with a second degree burn of lower back and upper back, burns that involved less than 10 % of body surface and eschar, and was discharged on the same date in about an hour.It was also reported that she had second degree burn in (b)(6) 2016 which was caused by a leakage of gel out of a patch.Her treatment included generic oxycodone orally and acetaminophen plus oxycodone (percocet) 7.5-325 mg per tablet every 6 hours (prn) as needed for pain and silver sulfadiazine (silvadene) ointment to apply for the burn.She was given several refills of her pain medication and silver sulfadiazine (silvadene) 1 % cream daily for the burn.She again went to the emergency on (b)(6) 2016 for pain after a burn and was discharged on the same date in about an hour and the diagnosis included burn of unspecified degree of upper back and burns that involved less than 10 % of body surface.The skin examination on (b)(6) 2016 showed upper central back lesion approximately 3 cm in diameter and eschar formed.On the same day, the medical impression was reported that her burn looked appropriately healing with no signs of infection, there was some mild erythema surrounding the area, which was very mild and looked like normal burn healing and the eschar had an area of white to it too that was healing.On (b)(6) 2016, she complained of pain to wound site for which she was taking pain medication.The skin examination on 1(b)(6) 2016 showed no acute lesions, 3 x 3 eschar to the upper back without erythema, induration, no drainage at the site and mild tenderness to palpitation.The follow-up visit diagnosis on (b)(6) 2016 included burns (any degree) that involved less than 10 % of body surface.On (b)(6) 2016, she took out-patient (op) wound therapy where the site was covered with thick adherent scab, intact skin surrounding full periwound area measuring 3 x 5.5 cm.She had chronic pain and the pain score was 8 in a scale of 1-10 at that point of time.She was instructed not to use silver sulfadiazine at that point of time as the scab acted as fully bio-occlusive dressing and instructed to apply silver sulfadiazine if there would be area of red/pink open.She was admitted to the hospital on (b)(6) 2016 and was discharged on (b)(6) 2016 for burn left shoulder.The diagnostic impression showed suspected superficial burn of back, chronic second degree burn of back and wound of left shoulder.She was initiated with silvasorb dressing thrice weekly after cleansing with soap and water and instructed to keep wound covered as directed.It was reported that after several months, she was left with very obvious scar on her neck in an area that can be seen by others.
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