|
|
| Lot Number S68523 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Skin Erosion (2075); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
|
| Event Date 02/23/2018 |
|
Event Type
Injury
|
|
Event Description
|
|
Burn, blistering/ pain [burns second degree], skin came off with the wrap [skin exfoliation], applied pressure over the area as she was in the car for about an hour [device use error], very hot [device issue].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) -year-old female patient started to receive thermacare heatwrap (thermacare menstrual), via an unspecified route of administration from (b)(6) 2018 for menstrual pain.Medical history included sensitive skin.Concomitant medication included ibuprofen (advil).On (b)(6) 2018, the patient applied the wrap to her pubic area and wore that wrap for about 8 hours.It was very hot so she had to put a paper towel between the wrap and her skin to keep from burning.On (b)(6) 2018, she applied another heatwrap.She stated she attached the adhesive to clothing and applied pressure over the area as she was in the car for about an hour.The patient checked her skin under the product while wearing thermacare because it was hurting after 45 minutes to an hour of applying the heatwrap.It was very hot so she had to put a paper towel between the wrap and her skin.After wearing the heatwrap for about 2 hours she felt the extreme pain.The patient removed the wrap and found there was a burn, blistering and skin came off with the wrap.She has 3 blisters about an inch wide that are the same size as the heating cells.She has not sought medical treatment but plans to apply vaseline to the area.The patient is not currently under the care of a physician for any medical condition.She classified her skin tone as fair and has sensitive skin; no abnormal skin conditions.The patient has previously used thermacare monthly for 10-20 years and has not experienced the same problem/symptom during previous use.The patient has also used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) when thermacare product was not available and has not experienced the same problem/symptom during previous use.She did not engage in exercise while using the product and did read the usage instructions on thermacare before using the product.The patient was not taking any medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the problem/symptom was experienced.The action taken in response to the event for thermacare heatwrap that burned her was permanently withdrawn on (b)(6) 2018.The outcome of burn, blistering/ pain, skin came off with the wrap and heatwrap very hot is not recovered.The outcome of applied pressure over the area as she was in the car for about an hour is recovered.The box and packages were sealed properly.Sample of the product is available to be returned.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" "skin exfoliation" "device use error" "device issue" as described are considered serious bodily injury potentially 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., comment: based on the information provided, the events of "burn blister" "skin exfoliation" "device use error" "device issue" as described are considered serious bodily injury potentially 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.
|
| |
|
Manufacturer Narrative
|
|
The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria per spec-(b)(4), effective date: (b)(4) 2016.Consumer reports a wrap "was so hot she had to place a paper towel between her skin and the wrap".The cause of the wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] burn, blistering/ pain [burns second degree], skin came off with the wrap [skin exfoliation], applied pressure over the area as she was in the car for about an hour [device use error], very hot [device issue].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6)-year-old other ethnic group ((b)(6)) female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number: s68523, expiration date apr2020) from (b)(6) 2018 for menstrual pain.The patient's medical history included sensitive skin.Concomitant medication included ibuprofen (advil).On (b)(6) 2018, the patient applied the wrap to her pubic area and wore that wrap for about 8 hours.It was very hot, so she had to put a paper towel between the wrap and her skin to keep from burning.On (b)(6) 2018, she applied another heatwrap.She stated she attached the adhesive to clothing and applied pressure over the area as she was in the car for about an hour.The patient checked her skin under the product while wearing thermacare because it was hurting after 45 minutes to an hour of applying the heatwrap.It was very hot, so she had to put a paper towel between the wrap and her skin.After wearing the heatwrap for about 2 hours she felt the extreme pain.The patient removed the wrap and found there was a burn, blistering and skin came off with the wrap.She has 3 blisters about an inch wide that are the same size as the heating cells.She has not sought medical treatment but plans to apply vaseline to the area.The patient is not currently under the care of a physician for any medical condition.She classified her skin tone as fair and has sensitive skin; no abnormal skin conditions.The patient has previously used thermacare monthly for 10-20 years and has not experienced the same problem/symptom during previous use.The patient has also used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) when thermacare product was not available and has not experienced the same problem/symptom during previous use.She did not engage in exercise while using the product and did read the usage instructions on thermacare before using the product.The patient was not taking any medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the problem/symptom was experienced.Action taken in response to the event for thermacare heatwrap that burned her was permanently withdrawn on (b)(6) 2018.The outcome of burn, blistering/ pain, skin came off with the wrap and heatwrap very hot is not recovered.The outcome of applied pressure over the area as she was in the car for about an hour is recovered.The box and packages were sealed properly.Sample of the product is available to be returned.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria per (b)(4), effective date: (b)(6) 2016.Consumer reports a wrap "was so hot she had to place a paper towel between her skin and the wrap".The cause of the wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Additional information has been requested and will be provided as it becomes available.Follow-up (14mar2018): new information received from product quality complaints (pqc) group included: suspect product lot number, expiration date and product quality investigation results.Company clinical evaluation comment: based on the information provided, the events of "burn blister" "skin exfoliation" "device use error" "device issue" as described are considered serious bodily injury potentially 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., comment: based on the information provided, the events of "burn blister" "skin exfoliation" "device use error" "device issue" as described are considered serious bodily injury potentially 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.
|
| |
|
Manufacturer Narrative
|
|
The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria per (b)(4), effective date: 28nov2016.Consumer reports a wrap "was so hot she had to place a paper towel between her skin and the wrap".The cause of the wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] burn, blistering/ pain [burns second degree], skin came off with the wrap [skin exfoliation], applied pressure over the area as she was in the car for about an hour [device use error], very hot [device issue].Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) other ethnic group ((b)(6)) female (non-pregnant) patient started to use thermacare heatwrap (thermacare menstrual) (device lot number: s68523, expiration date apr2020) from (b)(6) 2018 for menstrual pain.The patient's medical history included sensitive skin.Concomitant medication included ibuprofen (advil).On (b)(6) 2018, the patient applied the wrap to her pubic area and wore that wrap for about 8 hours.It was very hot so she had to put a paper towel between the wrap and her skin to keep from burning.On (b)(6) 2018, she applied another heatwrap.She stated she attached the adhesive to clothing and applied pressure over the area as she was in the car for about an hour.The patient checked her skin under the product while wearing thermacare because it was hurting after 45 minutes to an hour of applying the heatwrap.It was very hot so she had to put a paper towel between the wrap and her skin.After wearing the heatwrap for about 2 hours she felt the extreme pain.The patient removed the wrap and found there was a burn, blistering and skin came off with the wrap.She has 3 blisters about an inch wide that were the same size as the heating cells.She had not sought medical treatment but planned to apply vaseline to the area.The patient was not currently under the care of a physician for any medical condition.She classified her skin tone as fair and had sensitive skin; no abnormal skin conditions.The patient had previously used thermacare heatwraps monthly for 10-20 years and had not experienced the same problem/symptom during previous use.The patient had also used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) when thermacare product was not available and had not experienced the same problem/symptom during previous use.She did not engage in exercise while using the product and did read the usage instructions on thermacare before using the product.The patient was not taking any medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the problem/symptom was experienced.Action taken in response to the event for thermacare heatwrap that burned her was permanently withdrawn on (b)(6) 2018.The outcome of burn, blistering/ pain, skin came off with the wrap and heatwrap very hot is not recovered.The outcome of applied pressure over the area as she was in the car for about an hour is recovered.The box and packages were sealed properly.Sample of the product was available to be returned.Additional information received from product quality complaint (pqc) group included investigation results.Sample status: received - site.The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria per (b)(4), effective date: 28nov2016.Consumer reports a wrap "was so hot she had to place a paper towel between her skin and the wrap".The cause of the wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Additional information has been requested and will be provided as it becomes available.Follow-up (14mar2018): new information received from product quality complaints (pqc) group included: suspect product lot number, expiration date and product quality investigation results.Amendment: this follow-up report is being submitted to amend previously reported information: past drug is updated and device available for evaluation is updated from "yes" to "returned to manufacturer".Company clinical evaluation comment: based on the information provided, the events of burn blister, skin exfoliation, device use error, device issue as described are considered serious bodily injury potentially 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the information provided, the events of burn blister, skin exfoliation, device use error, device issue as described are considered serious bodily injury potentially 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
|
| |
|
Manufacturer Narrative
|
|
The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria per spec-(b)(4), effective date: (b)(6) 2016.Consumer reports a wrap "was so hot she had to place a paper towel between her skin and the wrap".The cause of the wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] burn, blistering/ pain [burns second degree], skin came off with the wrap [skin exfoliation], very hot [device issue], applied pressure over the area as she was in the car for about an hour [device use error].Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6)-year-old other race ((b)(6)) female (non-pregnant); patient started to use thermacare heatwrap (thermacare menstrual) (device lot number: s68523, expiration date apr2020) from 22feb2018 for menstrual pain.The patient's medical history included sensitive skin.Concomitant medication included ongoing ibuprofen (advil) at 2-4 daily as needed for menstrual pain.Past product history included thermacare heatwraps (thermacare heatwraps) monthly from an unspecified date for 10-20 years for an unspecified indication and had not experienced the below same problem/symptom.On (b)(6) 2018, the patient applied the wrap to her pubic area and wore that wrap for about 8 hours.It was very hot, so she had to put a paper towel between the wrap and her skin to keep from burning.On (b)(6) 2018, she applied another heatwrap.She stated she attached the adhesive to clothing and applied pressure over the area as she was in the car for about an hour.The patient checked her skin under the product while wearing thermacare because it was hurting after 45 minutes to an hour of applying the heatwrap.It was very hot so she had to put a paper towel between the wrap and her skin on (b)(6) 2018.After wearing the heatwrap for about 2 hours she felt the extreme pain on (b)(6) 2018.The patient removed the wrap and found there was a burn, blistering and skin came off with the wrap on (b)(6) 2018.She has 3 blisters about an inch wide that were the same size as the heating cells.She had not sought medical treatment but planned to apply vaseline to the area.The patient was not currently under the care of a physician for any medical condition.She classified her skin tone as fair and had sensitive skin; no abnormal skin conditions.The patient had also used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) when thermacare product was not available and had not experienced the same problem/symptom during previous use.She did not engage in exercise while using the product and did read the usage instructions on thermacare before using the product.The patient was not taking any medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the problem/symptom was experienced.Action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2018.The outcome of burn, blistering/pain, skin came off with the wrap and heatwrap very hot was not resolved.The outcome of applied pressure over the area as she was in the car for about an hour was resolved on (b)(6) 2018.The box and packages were sealed properly.Sample of the product was available to be returned.Additional information received from product quality complaint (pqc) group included investigation results.Sample status: received - site.The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria per (b)(4), effective date: (b)(6) 2016.Consumer reports a wrap "was so hot she had to place a paper towel between her skin and the wrap".The cause of the wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Additional information has been requested and will be provided as it becomes available.Follow-up (14mar2018): new information received from product quality complaints (pqc) group included: suspect product lot number, expiration date and product quality investigation results.Amendment: this follow-up report is being submitted to amend previously reported information: past drug is updated and device available for evaluation is updated from "yes" to "returned to manufacturer".Follow-up (18apr2018): new information received from a contactable other hcp (health professional) on behalf of physician includes added new reporter.Company clinical evaluation comment: based on the information provided, the events of burn blister, skin exfoliation, device use error, device issue as described are considered serious bodily injury potentially 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of burn blister, skin exfoliation, device use error, device issue as described are considered serious bodily injury potentially 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
|
| |
|
Manufacturer Narrative
|
|
The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria per (b)(4), effective date: (b)(6) 2016.Consumer reports a wrap "was so hot she had to place a paper towel between her skin and the wrap".The cause of the wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] burn, blistering/ pain [burns second degree], skin came off with the wrap [skin exfoliation], very hot [device issue], applied pressure over the area as she was in the car for about an hour [device use error].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) year-old other race ((b)(6)) female (non-pregnant) patient started to use thermacare heatwrap (thermacare menstrual) (device lot number: s68523, expiration date apr2020) from (b)(6) 2018 for menstrual pain.The patient's medical history included sensitive skin.Concomitant medication included ongoing ibuprofen (advil) at 2-4 daily as needed for menstrual pain.Past product history included thermacare heatwraps (thermacare heatwraps) monthly from an unspecified date for 10-20 years for an unspecified indication and had not experienced the below same problem/symptom.On (b)(6) 2018, the patient applied the wrap to her pubic area and wore that wrap for about 8 hours.It was very hot, so she had to put a paper towel between the wrap and her skin to keep from burning.On (b)(6) 2018, she applied another heatwrap.She stated she attached the adhesive to clothing and applied pressure over the area as she was in the car for about an hour.The patient checked her skin under the product while wearing thermacare because it was hurting after 45 minutes to an hour of applying the heatwrap.It was very hot so she had to put a paper towel between the wrap and her skin on (b)(6) 2018.After wearing the heatwrap for about 2 hours she felt the extreme pain on (b)(6) 2018.The patient removed the wrap and found there was a burn, blistering and skin came off with the wrap on (b)(6) 2018.She has 3 blisters about an inch wide that were the same size as the heating cells.She had not sought medical treatment but planned to apply vaseline to the area.The patient was not currently under the care of a physician for any medical condition.She classified her skin tone as fair and had sensitive skin; no abnormal skin conditions.The patient had also used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) when thermacare product was not available and had not experienced the same problem/symptom during previous use.She did not engage in exercise while using the product and did read the usage instructions on thermacare before using the product.The patient was not taking any medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the problem/symptom was experienced.Action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2018.The outcome of burn, blistering/pain, skin came off with the wrap and heatwrap very hot was not resolved.The outcome of applied pressure over the area as she was in the car for about an hour was resolved on (b)(6) 2018.The box and packages were sealed properly.Sample of the product was available to be returned.Additional information received from product quality complaint (pqc) group included investigation results.Sample status: received - site.The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria per (b)(4), effective date: (b)(6) 2016.Consumer reports a wrap "was so hot she had to place a paper towel between her skin and the wrap".The cause of the wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Additional information has been requested and will be provided as it becomes available.Follow-up (14mar2018): new information received from product quality complaints (pqc) group included: suspect product lot number, expiration date and product quality investigation results.Amendment: this follow-up report is being submitted to amend previously reported information: past drug is updated and device available for evaluation is updated from "yes" to "returned to manufacturer".Follow-up (18apr2018): new information received from a contactable other hcp (health professional) on behalf of physician includes added new reporter.Follow-up (30apr2018): new information received from a contactable physician includes: the physician denied being provided information regarding an adverse event with use of the product and could not confirm occurrence of the events reported by the patient.The physician declined any further correspondence.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment.Based on the information provided, the events of burn blister, skin exfoliation, device use error, device issue as described are considered serious bodily injury potentially 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.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 device use error 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 of burn blister, skin exfoliation, device use error, device issue as described are considered serious bodily injury potentially 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.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 device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
|
| |
|
Search Alerts/Recalls
|
|
|
