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| Lot Number L44886 |
| Device Problem
Improper or Incorrect Procedure or Method (2017)
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| Patient Problems
Erythema (1840); Full thickness (Third Degree) Burn (2696)
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| Event Date 12/05/2015 |
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Event Type
Injury
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Event Description
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She thinks she has 4th degree burns [burns fourth degree].Her skin was pulled off [skin exfoliation].Did not check under the product while wearing the heatwrap [intentional device misuse].She felt a tingling [paraesthesia].Today it is red like the product box [erythema].Case description: this is a spontaneous report from a contactable consumer reporting on behalf of herself.This (b)(6) year-old black female patient started to receive thermacare heatwrap (thermacare menstrual) (device lot number: l44886, expiration date: feb2018) from an unspecified date in (b)(6) 2015 for menstrual cramps.The patient's medical history was not reported.There were no concomitant medications.On an unspecified date in (b)(6) 2015, the patient used 2 of the 3 heatwraps from the package when she was on her cycle.She kept them on for approximately 4 hours each, attaching them to her clothing and experienced no adverse effects.On (b)(6) 2015, the patient had just showered, dried off, put her panties and a tank top on and laid back on her bed to watch television.She applied the third heatwrap from the package to her panties for menstrual cramps.The patient did not check the skin under the wrap during use.She got up to go to the bathroom and when she pulled down her panties she felt a tingling.That is when she noticed the burn.She reported before using the bathroom, she never got a burning sensation or anything to indicate the heatwrap was burning her.The patient stated she thinks she has 4th degree burns on the left side of the lower part of her belly.There was one big area where all the skin is burned off and all you can see is pink.She reported her skin was pulled off and on (b)(6) 2015, the patient stated "today it is red like the product box".The patient reported she is seeing her nurse practitioner on (b)(6) 2015 regarding the issue and a treatment plan will be established then.The patient assessed her skin tone as medium.She is not currently under the care of a physician for any medical conditions.The patient denied having sensitive skin or any abnormal skin conditions.She has not previously used other heat products for pain relief.The patient did not engage in exercise while using the product.She mentioned she read the usage instructions before using the product.The patient stated there was no folding of the wrap while she used it and it was not placed under her clothing at all.Action taken with suspect product was permanently withdrawn on (b)(6) 2015 as a result of the events.No therapeutic measures were taken.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 burn fourth degree, skin exfoliation, and intentional device misuse 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 events paresthesia and erythema are assessed as associated with the device use.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burn fourth degree, skin exfoliation, and intentional device misuse 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 events paresthesia and erythema are assessed as associated with the device use.This case meets initial 10-day eu and 30-day fda reportability.
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Event Description
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She thinks she has 4th degree burns [burns fourth degree].Her skin was pulled off [skin exfoliation].Second degree burns [burns second degree].Did not check under the product while wearing the heatwrap [intentional device misuse].She felt a tingling [paraesthesia].It is red like the product box [erythema].Scarred for life, devastated and disturbed by burn [fear].Case description: this is a spontaneous report from a contactable consumer reporting on behalf of herself.This (b)(6) black female patient started to receive thermacare heatwrap (thermacare menstrual) (device lot number: l44886, expiration date: feb 2018) from an unspecified date in (b)(6) 2015 for menstrual cramps.The patient's medical history was not reported.There were no concomitant medications.On an unspecified date in (b)(6) 2015, the patient used 2 of the 3 heatwraps from the package when she was on her cycle.She kept them on for approximately 4 hours each, attaching them to her clothing and experienced no adverse effects.On (b)(6) 2015, the patient had just showered, dried off, put her panties and a tank top on and laid back on her bed to watch television.She applied the third heatwrap from the package to her panties for menstrual cramps.The patient did not check the skin under the wrap during use.Four hours later, she got up to go to the bathroom and when she pulled down her panties and felt air hit her stomach, she felt a tingling, and look down and had this burn.She immediately removed the product.She reported before using the bathroom, she never got a burning sensation or anything to indicate the heatwrap was burning her.The patient stated she thinks she has 4th degree burns on the left side of the lower part of her belly.There was one big area where all the skin is burned off and all you can see is pink and red.She reported her skin was pulled off and on (b)(6) 2015, the patient stated "today it is red like the product box".The patient went to doctor and was told she has a second degree burn.Physician prescribed medication for her, but the patient has not picked up yet.The patient stated she was damaged, scar is not going to go away, scarred for life, devastated and disturbed by burn.The patient assessed her skin tone as medium.She is not currently under the care of a physician for any medical conditions.The patient denied having sensitive skin or any abnormal skin conditions.She has not previously used other heat products for pain relief.The patient did not engage in exercise while using the product.She mentioned she read the usage instructions before using the product.The patient stated there was no folding of the wrap while she used it and it was not placed under her clothing at all.Action taken with suspect product was permanently withdrawn on (b)(6) 2015 as a result of the events.No therapeutic measures were taken for the events.Clinical outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (09dec2015): new information reported from (b)(6) from the same contactable consumer included: new events (second degree burns, scarred for life, devastated and disturbed by burn, it is not going to go away).Company clinical evaluation comment based on the information provided, the events burn fourth degree, burn second degree, skin exfoliation, and intentional device misuse 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 events paresthesia, fear, and erythema are assessed as associated with the device use.This case meets follow up 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burn fourth degree, burn second degree,skin exfoliation, and intentional device misuse 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 events paresthesia, fear, and erythema are assessed as associated with the device use.This case meets follow up 10-day eu and 30-day fda reportability.
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Event Description
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She thinks she has 4th degree burns [burns fourth degree].Her skin was pulled off [skin exfoliation].Second degree burns/partial thickness burn [burns second degree].Did not check under the product while wearing the heatwrap [intentional device misuse].She felt a tingling [paraesthesia].It is red like the product box [erythema].Scarred for life, devastated and disturbed by burn [fear].Case description: this is a spontaneous report from a contactable consumer reporting on behalf of herself and follow-up report received from a contactable nurse.This (b)(6)-year-old black female patient started to receive thermacare heatwrap (thermacare menstrual) (device lot number: l44886, expiration date: feb2018) from an unspecified date in (b)(6) 2015 for menstrual cramps.Not pregnant.The patient's medical history was none.There were no concomitant medications.On an unspecified date in (b)(6) 2015, the patient used 2 of the 3 heatwraps from the package when she was on her cycle.She kept them on for approximately 4 hours each, attaching them to her clothing and experienced no adverse effects.On (b)(6) 2015, the patient had just showered, dried off, put her panties and a tank top on and laid back on her bed to watch television.She applied the third heatwrap from the package to her panties for menstrual cramps.The patient did not check the skin under the wrap during use.4 hours later, she got up to go to the bathroom and when she pulled down her panties and felt air hit her stomach, she felt a tingling, and look down and had this burn.She immediately removed the product.She reported before using the bathroom, she never got a burning sensation or anything to indicate the heatwrap was burning her.The patient stated she thinks she has 4th degree burns on the left side of the lower part of her belly.There was one big area where all the skin is burned off and all you can see is pink and red.She reported her skin was pulled off and on (b)(6) 2015, the patient stated "today it is red like the product box".The patient went to doctor and was told she has a second degree burn.Physician prescribed medication for her, but the patient has not picked up yet.The patient stated she was damaged, scar is not going to go away, scarred for life, devastated and disturbed by burn.The patient assessed her skin tone as medium.She is not currently under the care of a physician for any medical conditions.The patient denied having sensitive skin or any abnormal skin conditions.She has not previously used other heat products for pain relief.The patient did not engage in exercise while using the product.She mentioned she read the usage instructions before using the product.The patient stated there was no folding of the wrap while she used it and it was not placed under her clothing at all.While on follow-up, the nurse reported patient had no prior medical history; no relevant drug history; no drug or alcohol abuse; no drug allergies; no family history.The nurse considered the pfizer product had a causal effect to the adverse event.The nurse considered there is no event was considered serious due to being life-threatening, or due to persistent or significant disability/incapacity or any other reason.Patient was not deceased.No surgical intervention for lower abdomen approx.2x inches partial thickness burn, such as debridement required.The treatment included silvadene cream apply thin film 1-2 x daily, keflex 500mg q 12 x 10 day, ibuprofen 800mg q 8 prn po to prevention of infection partial thickness burn since (b)(6) 2015.The nurse expected the patient to experience long-term sequelae such as probable scaring.Action taken with suspect product was permanently withdrawn on (b)(6) 2015 as a result of the events.Clinical outcome of the events was recovering.Additional information has been requested and will be provided as it becomes available.Follow-up (09dec2015): new information reported from a pfizer-sponsored program pfizer rxpathways from the same contactable consumer included: new events (second degree burns, scarred for life, devastated and disturbed by burn, it is not going to go away).Follow-up (04jan2016): new information received from a contactable nurse included: causality assessment, treatment information.No admitted to hospital, events outcome.Relevant history.New event description "lower abdomen approx.2x inches partial thickness burn." follow up attempts completed.No further information expected.Company clinical evaluation comment based on the information provided, the events burn fourth degree, burn second degree, skin exfoliation, and intentional device misuse 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 events paresthesia, fear, and erythema are assessed as associated with the device use.This case meets follow up 10-day (b)(6) and 30-day fda reportability.Case comment: based on the information provided, the events burn fourth degree, burn second degree,skin exfoliation, and intentional device misuse 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 events paresthesia, fear, and erythema are assessed as associated with the device use.This case meets follow up 10-day (b)(6) and 30-day fda reportability.
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Manufacturer Narrative
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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, 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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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 reporting on behalf of herself and follow-up report received from a contactable nurse.This (b)(6)-year-old (b)(6) female patient started to receive thermacare heatwrap (thermacare menstrual) (device lot number: l44886, expiration date: feb2018) from an unspecified date in (b)(6) 2015 for menstrual cramps.Not pregnant.The patient's medical history was none.There were no concomitant medications.On an unspecified date in (b)(6) 2015, the patient used 2 of the 3 heatwraps from the package when she was on her cycle.She kept them on for approximately 4 hours each, attaching them to her clothing and experienced no adverse effects.On (b)(6) 2015, the patient had just showered, dried off, put her panties and a tank top on and laid back on her bed to watch television.She applied the third heatwrap from the package to her panties for menstrual cramps.The patient did not check the skin under the wrap during use.4hours later, she got up to go to the bathroom and when she pulled down her panties and felt air hit her stomach, she felt a tingling, and look down and had this burn.She immediately removed the product.She reported before using the bathroom, she never got a burning sensation or anything to indicate the heatwrap was burning her.The patient stated she thinks she has 4th degree burns on the left side of the lower part of her belly.There was one big area where all the skin is burned off and all you can see is pink and red.She reported her skin was pulled off and on (b)(6) 2015, the patient stated "today it is red like the product box".The patient went to doctor and was told she has a second degree burn.Physician prescribed medication for her, but the patient has not picked up yet.The patient stated she was damaged, scar is not going to go away, scarred for life, devastated and disturbed by burn.The patient assessed her skin tone as medium.She is not currently under the care of a physician for any medical conditions.The patient denied having sensitive skin or any abnormal skin conditions.She has not previously used other heat products for pain relief.The patient did not engage in exercise while using the product.She mentioned she read the usage instructions before using the product.The patient stated there was no folding of the wrap while she used it and it was not placed under her clothing at all.While on follow-up, the nurse reported patient had no prior medical history; no relevant drug history; no drug or alcohol abuse; no drug allergies; no family history.The nurse considered the pfizer product had a causal effect to the adverse event.The nurse considered there is no event was considered serious due to being life-threatening, or due to persistent or significant disability/incapacity or any other reason.Patient was not deceased.No surgical intervention for lower abdomen approx.2x inches partial thickness burn, such as debridement required.The treatment included silvadene cream apply thin film 1-2 x daily, keflex 500mg q 12 x 10 day, ibuprofen 800mg q 8 prn po to prevention of infection partial thickness burn since (b)(6) 2015.The nurse expected the patient to experience long-term sequelae such as probable scaring.Action taken with suspect product was permanently withdrawn on (b)(6) 2015 as a result of the events.Clinical outcome of the events was recovering.According to the product quality complaint group: 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, 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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2015): new information reported from a pfizer-sponsored program pfizer rxpathways from the same contactable consumer included: new events (second degree burns, scarred for life, devastated and disturbed by burn, it is not going to go away).Follow-up ((b)(6) 2016): new information received from a contactable nurse included: causality assessment, treatment information.No admitted to hospital, events outcome.Relevant history.New event description "lower abdomen approx.2x inches partial thickness burn" follow up attempts completed.No further information expected.Follow-up ((b)(6) 2016): new information received from the product quality complaint group included investigational results.Follow-up attempts completed.No further information expected.Company clinical evaluation comment based on the information provided, the events burn fourth degree, burn second degree, skin exfoliation, and intentional device misuse 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 events paresthesia, fear, and erythema are assessed as associated with the device use.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burn fourth degree, burn second degree, skin exfoliation, and intentional device misuse 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 events paresthesia, fear, and erythema are assessed as associated with the device use.This case meets final 10-day eu and 30-day fda reportability.Evaluation summary: 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, 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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.
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Event Description
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She thinks she has 4th degree burns [burns fourth degree].Her skin was pulled off [skin exfoliation].Second degree burns/partial thickness burn [burns second degree].Did not check under the product while wearing the heatwrap [intentional device misuse].Permanent visible scarring on her stomach and pubic region [scar].She felt a tingling [paraesthesia].It is red like the product box [erythema].Scarred for life, devastated and disturbed by burn [fear].Case description: this is a spontaneous report from a contactable consumer reporting on behalf of herself and follow-up report received from a contactable nurse.This (b)(6)-year-old black female patient started to receive thermacare heatwrap (thermacare menstrual) (device lot number: l44886, expiration date: feb2018) from an unspecified date in (b)(6) 2015 for menstrual cramps.Not pregnant.The patient's medical history was none.There were no concomitant medications.On an unspecified date in (b)(6) 2015, the patient used 2 of the 3 heatwraps from the package when she was on her cycle.She kept them on for approximately 4 hours each, attaching them to her clothing and experienced no adverse effects.On (b)(6) 2015, the patient had just showered, dried off, put her panties and a tank top on and laid back on her bed to watch television.She applied the third heatwrap from the package to her panties for menstrual cramps.The patient did not check the skin under the wrap during use.Four hours later, she got up to go to the bathroom and when she pulled down her panties and felt air hit her stomach, she felt a tingling, and look down and had this burn.She immediately removed the product.She reported before using the bathroom, she never got a burning sensation or anything to indicate the heatwrap was burning her.The patient stated she thinks she has 4th degree burns on the left side of the lower part of her belly.There was one big area where all the skin is burned off and all you can see is pink and red.She reported her skin was pulled off and on (b)(6) 2015, the patient stated "today it is red like the product box".The patient went to doctor and was told she has a second degree burn.Physician prescribed medication for her, but the patient has not picked up yet.The patient stated she was damaged, scar is not going to go away, scarred for life, devastated and disturbed by burn.The patient assessed her skin tone as medium.She is not currently under the care of a physician for any medical conditions.The patient denied having sensitive skin or any abnormal skin conditions.She has not previously used other heat products for pain relief.The patient did not engage in exercise while using the product.She mentioned she read the usage instructions before using the product.The patient stated there was no folding of the wrap while she used it and it was not placed under her clothing at all.While on follow-up, the nurse reported patient had no prior medical history; no relevant drug history; no drug or alcohol abuse; no drug allergies; no family history.The nurse considered the pfizer product had a causal effect to the adverse event.The nurse considered there is no event was considered serious due to being life-threatening, or due to persistent or significant disability/incapacity or any other reason.Patient was not deceased.No surgical intervention for lower abdomen approx.2x inches partial thickness burn, such as debridement required.The treatment included silvadene cream apply thin film 1-2 x daily, keflex 500mg q 12 x 10 day, ibuprofen 800mg q 8 prn po to prevention of infection partial thickness burn since (b)(6) 2015.The nurse expected the patient to experience long-term sequelae such as probable scaring.Action taken with suspect product was permanently withdrawn on (b)(6) 2015 as a result of the events.Clinical outcome of the events was recovering.According to the product quality complaint group: 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, 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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (09dec2015): new information reported from a pfizer-sponsored program pfizer rxpathways from the same contactable consumer included: new events (second degree burns, scarred for life, devastated and disturbed by burn, it is not going to go away).Follow-up (04jan2016): new information received from a contactable nurse included: causality assessment, treatment information.No admitted to hospital, events outcome.Relevant history.New event description "lower abdomen approx.2x inches partial thickness burn." follow up attempts completed.No further information expected.Follow-up (11feb2016): new information received from the product quality complaint group included investigational results.Follow-up attempts completed.No further information expected.Follow-up (12may2016): this contactable attorney reported by way of claim letter.This female patient's burn had turned in color and began to appear visually worsened on (b)(6) 2015.She had permanent visible scarring on her stomach and pubic region on an unknown date.She applied a cool damp cloth before treating the wound with an antibacterial ointment on (b)(6) 2015.On (b)(6) 2015, she underwent unknown treatment for second degree burns of her lower stomach and upper pubic regions.As of (b)(6) 2016, the clinical outcome of the event permanent visible scarring on her stomach and pubic region was not recovered.
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Manufacturer Narrative
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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, 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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.
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Event Description
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She thinks she has 4th degree burns [burns fourth degree] her skin was pulled off [skin exfoliation] second degree burns/partial thickness burn [burns second degree] did not check under the product while wearing the heatwrap [intentional device misuse] permanent visible scarring on her stomach and pubic region [scar] red, painful blisters/pain [blister] red, painful blisters/pain [pain] she felt a tingling [paraesthesia] it is red like the product box [erythema] scarred for life, devastated and disturbed by burn [fear] case description: this is a spontaneous report from a contactable consumer reporting on behalf of herself and follow-up report received from a contactable nurse.This (b)(6) black female patient started to receive thermacare heatwrap (thermacare menstrual) (device lot number: l44886, expiration date: feb2018) from an unspecified date in (b)(6) 2015 for menstrual cramps.Not pregnant.The patient's medical history was none.There were no concomitant medications.On an unspecified date in (b)(6) 2015, the patient used 2 of the 3 heatwraps from the package when she was on her cycle.She kept them on for approximately 4 hours each, attaching them to her clothing and experienced no adverse effects.On (b)(6) 2015, the patient had just showered, dried off, put her panties and a tank top on and laid back on her bed to watch television.She applied the third heatwrap from the package to her panties for menstrual cramps.The patient did not check the skin under the wrap during use.4hours later, she got up to go to the bathroom and when she pulled down her panties and felt air hit her stomach, she felt a tingling, and look down and had this burn.She immediately removed the product.She reported before using the bathroom, she never got a burning sensation or anything to indicate the heatwrap was burning her.The patient stated she thinks she has 4th degree burns on the left side of the lower part of her belly.There was one big area where all the skin is burned off and all you can see is pink and red.She reported her skin was pulled off and on (b)(6) 2015, the patient stated "today it is red like the product box".The patient went to doctor and was told she has a second degree burn.Physician prescribed medication for her, but the patient has not picked up yet.The patient stated she was damaged, scar is not going to go away, scarred for life, devastated and disturbed by burn.The patient assessed her skin tone as medium.She is not currently under the care of a physician for any medical conditions.The patient denied having sensitive skin or any abnormal skin conditions.She has not previously used other heat products for pain relief.The patient did not engage in exercise while using the product.She mentioned she read the usage instructions before using the product.The patient stated there was no folding of the wrap while she used it and it was not placed under her clothing at all.While on follow-up, the nurse reported patient had no prior medical history; no relevant drug history; no drug or alcohol abuse; no drug allergies; no family history.The nurse considered the pfizer product had a causal effect to the adverse event.The nurse considered there is no event was considered serious due to being life-threatening, or due to persistent or significant disability/incapacity or any other reason.Patient was not deceased.No surgical intervention for lower abdomen approx.2x inches partial thickness burn, such as debridement required.The treatment included silvadene cream apply thin film 1-2 x daily, keflex 500mg q 12 x 10 day, ibuprofen 800mg q 8 prn po to prevention of infection partial thickness burn since (b)(6) 2015.The nurse expected the patient to experience long-term sequelae such as probable scaring.Action taken with suspect product was permanently withdrawn on (b)(6) 2015 as a result of the events.Clinical outcome of the events was recovering.According to the product quality complaint group: 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, 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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (09dec2015): new information reported from a pfizer-sponsored program pfizer rxpathways from the same contactable consumer included: new events (second degree burns, scarred for life, devastated and disturbed by burn, it is not going to go away).Follow-up (04jan2016): new information received from a contactable nurse included: causality assessment, treatment information.No admitted to hospital, events outcome.Relevant history.New event description "lower abdomen approx.2x inches partial thickness burn".Follow up attempts completed.No further information expected.Follow-up (11feb2016): new information received from the product quality complaint group included investigational results.Follow-up attempts completed.No further information expected.Follow-up (12may2016): this contactable attorney reported by way of claim letter.This female patient's burn had turned in color and began to appear visually worsened on (b)(6) 2015.She had permanent visible scarring on her stomach and pubic region on an unknown date.She applied a cool damp cloth before treating the wound with an antibacterial ointment on (b)(6) 2015.On (b)(6) 2015, she underwent unknown treatment for second degree burns of her lower stomach and upper pubic regions.As of (b)(6) 2016, the clinical outcome of the event permanent visible scarring on her stomach and pubic region was not recovered.Follow-up (20sep2016): this contactable consumer reported by way of consumer questionnaire and medical records.This female patient reported that thermacare heat wrap was not heated in microwave, not reheated at all, not applied directly to the skin and nor applied while sleeping.She also reported that product was applied just as demonstrated on the package, adhesive side was on panties and the cotton side was touching the lower part of stomach where cramps were significant.Her relevant medical history included painful menses for years and problems with menstrual cycles include heavy bleeding on an unknown date.Her family history included hypertension (mother) on an unknown date.In (b)(6) 2015, nurse had an impression that patient had red, painful blisters on the lower abdomen indicative of a second degree burn which occurred due to thermacare heat wrap.After patch was removed in (b)(6) 2015, she noticed pain and approximately 2x1 inch area of partial thickness (2nd degree) burn and raw area where skin was off.The area was very sore and she was treated with neosporin and unknown antibiotic ointment.The treatment medication included silver sulfadiazine (silvadene) 1% cream thin film applied to affected area 1 to 2 times daily for burn.As of (b)(6) 2016, the clinical outcome of the events red, painful blisters/pain was unknown.
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Search Alerts/Recalls
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