|
|
| Lot Number S68523 |
| Device Problem
Insufficient Information (3190)
|
| Patient Problems
Skin Erosion (2075); Burn, Thermal (2530)
|
| Event Date 12/08/2017 |
|
Event Type
Injury
|
|
Event Description
|
|
Event verbatim [preferred term] a little burn described as small little round dots, an additional one that is little bit below her stomach area [thermal burn] , thin layer of skin had come off [skin exfoliation].Case narrative: this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) -year-old caucasian female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number s68523, expiration date apr2020) from an unspecified date for menstrual cramps.Medical history was reported as none.There were no concomitant medications.The patient previously used thermacare heatwrap (thermacare menstrual) on an unspecified date and experienced the heatwrap did not heat up, didn't get warm or anything.On (b)(6) 2017, the patient experienced a little burn which has never happened before.The burn was described as small, little round dots located in two different spots around her stomach area.There is an additional one that is little bit below her stomach area.The size of the burns is no more than dime size.One of the areas has like three small burns together, bunched together.The burns were hot, she noticed when she took the product off.This was in the middle of the day.The patient had only worn the heatwrap for 3 hours.She stated a thin layer of skin had come off.The patient did not consult a physician as a result of the events.Therapeutic measures taken included neosporin.Action taken with the suspect product was continued.Clinical outcome of the event was resolving.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" "thin layer of skin had come off" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "burn" "thin layer of skin had come off" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.
|
| |
|
Manufacturer Narrative
|
|
The root cause category is non-assignable (complaint not confirmed).Consumer reports a wrap "give her a little burn".The cause of the burn 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.After a review of the batch thermal records, thermal results all met product release criteria per #, effective date: 28nov2016.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] a little burn described as small little round dots, an additional one that is little bit below her stomach area/burns [thermal burn] , thin layer of skin had come off [skin exfoliation].Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number s68523, expiration date apr2020) from (b)(6) 2017 for menstrual cramps.The patient's medical history included allergies.The patient reported she was not pregnant.Concomitant medications included citalopram from an unspecified date at 40mg daily and ongoing for allergy and claritin from an unspecified date at 10mg daily and ongoing for allergy.The patient previously used thermacare heatwrap (thermacare menstrual) on an unspecified date and experienced the heatwrap did not heat up, didn't get warm or anything.On (b)(6) 2017 at 9 a.M.(previously reported as (b)(6) 2017), the patient experienced a little burn which has never happened before.The burn was described as small, little round dots located in two different spots around her stomach area.There is an additional one that is little bit below her stomach area.The size of the burns is no more than dime size.One of the areas has like three small burns together, bunched together.The burns were hot, she noticed when she took the product off at 11 a.M.The patient had attached the heatwrap's adhesive to her clothing and wore the heatwrap for approximately 2 hours.She stated a thin layer of skin had come off.The patient did not consult a physician as a result of the events.The patient assessed her skin tone as medium (neither light nor dark).She denied having sensitive skin or any abnormal skin conditions.The patient mentioned the heatwrap was purchased in a red box.She stated she previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) but did not experience any similar symptoms with use.The patient did not engage in exercise while using the product.She stated she did check her skin under the heatwrap every hour while wearing the product.The patient had read the usage instructions prior to heatwrap use.Action taken with the suspect product was permanently withdrawn on (b)(6) 2017 at 11 a.M.Therapeutic measures taken included neosporin.No hospitalization was required as a result of the events.Clinical outcome of the event was resolved on (b)(6)2018.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).Consumer reports a wrap "give her a little burn".The cause of the burn 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.After a review of the batch thermal records, thermal results all met product release criteria per #, effective date: 28nov2016.Additional information has been requested and will be provided as it becomes available.Follow-up (23jan2018): new information received from a contactable consumer includes: patient's medical history, suspect product start/stop dates, action taken with suspect product, concomitant medications, updated event onset date, event outcome and no hospitalization required.Follow-up (23jan2018): new information received from product quality complaints (pqc) group included: product quality investigation results.Company clinical evaluation comment: based on the information provided, the events of "burn" "thin layer of skin had come off" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "burn""thin layer of skin had come off" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.
|
| |
|
Manufacturer Narrative
|
|
The root cause category is non-assignable (complaint not confirmed).Consumer reports a wrap "give her a little burn".The cause of the burn 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.After a review of the batch thermal records, thermal results all met product release criteria per #, effective date: (b)(6) 2016.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] a little burn described as small little round dots, an additional one that is little bit below her stomach area/burns [thermal burn] , thin layer of skin had come off [skin exfoliation] ,.Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6)-year-old (b)(6) female patient started to use thermacare heatwrap (thermacare menstrual)(device lot number s68523, expiration date apr2020) from (b)(6) 2017 for menstrual cramps.The patient's medical history included allergies.The patient reported she was not pregnant.Concomitant medications included citalopram from an unspecified date at 40mg daily and ongoing for allergy and claritin from an unspecified date at 10mg daily and ongoing for allergy.The patient previously used thermacare heatwrap (thermacare menstrual) on an unspecified date and experienced the heatwrap did not heat up, didn't get warm or anything.On (b)(6) 2017 at 9 a.M.(previously reported as (b)(6) 2017), the patient experienced a little burn which has never happened before.The burn was described as small, little round dots located in two different spots around her stomach area.There is an additional one that is little bit below her stomach area.The size of the burns is no more than dime size.One of the areas has like three small burns together, bunched together.The burns were hot, she noticed when she took the product off at 11 a.M.The patient had attached the heatwrap's adhesive to her clothing and wore the heatwrap for approximately 2 hours.She stated a thin layer of skin had come off.The patient did not consult a physician as a result of the events.The patient assessed her skin tone as medium (neither light nor dark).She denied having sensitive skin or any abnormal skin conditions.The patient mentioned the heatwrap was purchased in a red box.She stated she previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) but did not experience any similar symptoms with use.The patient did not engage in exercise while using the product.She stated she did check her skin under the heatwrap every hour while wearing the product.The patient had read the usage instructions prior to heatwrap use.Action taken with the suspect product was permanently withdrawn on (b)(6) 2017 at 11 a.M.Therapeutic measures taken included neosporin.No hospitalization was required as a result of the events.Clinical outcome of the event was resolved on (b)(6) 2018.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).Consumer reports a wrap "give her a little burn".The cause of the burn 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.After a review of the batch thermal records, thermal results all met product release criteria per #, effective date: (b)(6) 2016.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2018): new information received from a contactable consumer includes: patient's medical history, suspect product start/stop dates, action taken with suspect product, concomitant medications, updated event onset date, event outcome and no hospitalization required.Follow-up ((b)(6) 2018): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up ((b)(6) 2018): new information received from a contactable other hcp includes: the other hcp 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.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment.Based on the information provided, the events of "burn" "thin layer of skin had come off" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "burn""thin layer of skin had come off" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.
|
| |
|
Event Description
|
|
Event verbatim [preferred term]: a little burn described as small little round dots.An additional one that is little bit below her stomach area/burns [thermal burn], thin layer of skin had come off [skin exfoliation].Case narrative:this is a spontaneous report from a contactable consumer.A 42-year-old female patient started to use thermacare heatwrap (thermacare menstrual), (device lot number s68523, expiration date apr2020) from (b)(6) 2017 for menstrual cramps.The patient's medical history included: ongoing allergies.The patient reported, she was not pregnant.Concomitant medications included: citalopram from an unspecified date at 40mg daily and ongoing for allergy.And loratadine (claritin) from an unspecified date at 10mg daily and ongoing for allergy.The patient previously used thermacare heatwrap (thermacare menstrual) on an unspecified date.And experienced the heatwrap did not heat up, didn't get warm or anything.The patient used the product on (b)(6) 2017 at 9 a.M.(previously reported as (b)(6)2017), experienced a little burn at 11 am which has never happened before.The burn was described as small, little round dots located in two different spots around her stomach area.There is an additional one, that is little bit below her stomach area.The size of the burns is no more than dime size.One of the areas has like three small burns together, bunched together.The burns were hot, she noticed, when she took the product off at 11 a.M.The patient had attached the heatwrap'ss adhesive to her clothing and wore the heatwrap for approximately 2 hours.She stated, a thin layer of skin had come off.The patient did not consult a physician as a result of the events.The patient assessed her skin tone as medium (neither light nor dark).She denied having sensitive skin or any abnormal skin conditions.The patient mentioned, the heatwrap was purchased in a red box.She stated, she previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack), but did not experience any similar symptoms with use.The patient did not engage in exercise while using the product.She stated, she did check her skin under the heatwrap every hour, while wearing the product.The patient had read the usage instructions prior to heatwrap use.A sample of the product was available to be returned if requested.Action taken with the suspect product was permanently withdrawn on 08dec2017 at 11 a.M.Therapeutic measures taken included neosporin.No hospitalization was required as a result of the events.Clinical outcome of the event was resolved on (b)(6) 2018.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).Consumer reports a wrap "give her a little burn".The cause of the burn 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.After a review of the batch thermal records, thermal results all met product release criteria per #, effective date: 28nov2016.Follow-up ((b)(6) 2018), new information received from a contactable consumer includes: patient's medical history, suspect product start/stop dates, action taken with suspect product, concomitant medications, updated event onset date, event outcome and no hospitalization required.Follow-up (23jan2018), new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up ((b)(6) 2018), new information received from a contactable other hcp includes: the other hcp 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.Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information.Ongoing was checked for medical history, evaluation codes updated, product notes updated.Comment: based on the information provided, the events of "burn, thin layer of skin had come off" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.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).Consumer reports a wrap "give her a little burn".The cause of the burn 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.After a review of the batch thermal records, thermal results all met product release criteria per #, effective date: 28nov2016.
|
| |
|
Search Alerts/Recalls
|
|
|
