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| Lot Number R44751 |
| Device Problem
Overheating of Device (1437)
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| Patient Problems
Pyrosis/Heartburn (1883); Cramp(s) (2193); Burn, Thermal (2530)
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| Event Date 02/14/2017 |
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Event Type
Injury
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Event Description
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Burn/same size and shape of a heat cell, also compared it to a quarter [thermal burn] , the skin has completely come off [skin exfoliation] , she did not check skin under the product while wearing [device use error].She read the usage instructions on thermacare before using the product [intentional device misuse].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) female patient started to use thermacare heatwrap (thermacare menstrual) from (b)(6) 2017 for cramps.Medical history included uterine leiomyoma from an unknown date and unknown if ongoing, she was seeing an obgyn for uterine fibroids, would be having surgery for this soon, heartburn from an unknown date and unknown if ongoing.Concomitant medication included esomeprazole magnesium (nexium) at 40 mg, 1x/day for heartburn from 2016 and ibuprofen at 400 mg, single for cramps.The patient previously took thermacare heatwraps and did not have adverse event.She stated she bought thermacare menstrual wraps a couple of days ago.She wore it to work for maybe 4 hours yesterday, (b)(6) 2017, and she had a burn on her stomach area.She attached the wrap to her underwear as the instructions suggested.Wore the wrap for 4 hours while at work.Stated that she was sitting in a chair for most of that time.She wore the wrap for about 4 hours, and when she took it off, she noticed a burn.She still had an imprint of the heat cells all over her stomach where the wrap was, but there was only one spot on the left side that actually burned.The burn was the same size and shape of a heat cell, also compared it to a quarter.The skin had completely come off, and was now just a white spot.She did not feel that it was necessary to go to the doctor.She had been keeping the burn covered, and had been putting vaseline on it.She stated she might try to put some neosporin on it to help bring the color back.The patient did not have diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis, decreased sensation and neuropathy.The patient classified her skin tone as medium (neither light nor dark), stated that she was brown.The patient did not have sensitive skin or abnormal skin conditions.She had 2 unused wraps.Lot number and expiration date was unknown because she didn't have the product with her.The patient had previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) and did not experienced any problems.She did not engage in exercise while using the product.She did not check skin under the product while wearing.She read the usage instructions on thermacare before using the product.She also complained the heat didn't usually last the full 8 hours.She stated she noticed this when she first started using the wraps.This was a long time ago, and she no longer had any of the product left to provide lot number, upc, or expiration date.The action taken with thermacare heatwraps was temporary withdrawn on (b)(4) 2017.Outcome of event burn and skin completely come off was not resolved, other events outcome was unknown.According to the reporting consumer the device was not available to be returned for evaluation.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the reported events thermal burn, skin exfoliation, device use error, and intentional device misuse as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] burn/same size and shape of a heat cell, also compared it to a quarter [thermal burn], the skin has completely come off [skin exfoliation], she did not check skin under the product while wearing [device use error], she did not check skin under the product while wearing.She read the usage instructions on thermacare before using the product [intentional device misuse], scar [scar].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) black (other african american) not pregnant female patient started to use thermacare heatwrap (thermacare menstrual), lot number: r44751 s oct2006 and expiration date: sep2019, from (b)(6) 2017 at 1 wrap unknown frequency for cramps.Medical history included uterine leiomyoma that she was seeing an obgyn for uterine fibroids and would be having surgery for this soon, heartburn.The patient did not have diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis, decreased sensation and neuropathy.Concomitant medication included esomeprazole magnesium (nexium) at 40 mg, once a day for heartburn from 2016 and ongoing and ibuprofen at 400 mg, single for cramps from (b)(6) 2017 and ongoing.The patient did not previously used thermacare.The patient had previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) and did not experienced any problems.She stated she bought thermacare mentrual wraps a couple of days before the report.She wore it to work for might be 4 hours yesterday, (b)(6) 2017, and she had a burn on her stomach area.She attached the wrap to her underwear as the instructions suggested.Wore the wrap for 4 hours while at work.Stated that she was sitting in a chair for most of that time.The patient wore thermacare not long might be 4 hours, might be not more than 4.She wore the wrap for about 4 hours, and when she took it off, she noticed a burn.She still had an imprint of the heat cells all over her stomach where the wrap was, but there was only one spot on the left side that actually burned.The burn was the same size and shape of a heat cell, also compared it to a quarter.The skin had completely come off, and was now just a white spot.She did not feel that it was necessary to go to the doctor.She had been keeping the burn covered, and had been putting vaseline on it.She stated she might try to put some bacitracin, neomycin sulfate, polymyxin b sulfate (neosporin) on it to help bring the color back.The patient classified her skin tone as medium (neither light nor dark), stated that she was brown.The patient did not have sensitive skin or abnormal skin conditions.She had 2 unused wraps.Lot number and expiration date was unknown because she didn't have the product with her.She did not engage in exercise while using the product.She did not check skin under the product while wearing on (b)(6) 2017.The patient did have sensitive skin and did not have any abnormal skin conditions.The patient attached adhesive to clothing.She read the usage instructions on thermacare before using the product.She also complained the heat didn't usually last the full 8 hours.She stated she noticed this when she first started using the wraps.This was a long time ago, and she no longer had any of the product left to provide lot number, upc, or expiration date.The patient was not hospitalized due to event burn.The patient was hospitalized due to the skin had completely come off.The patient received over the counter (otc) treatment for event the skin had completely come off.The patient further reported "the burn healed, i do have pictures.But the scar was still there.I believe i should be compensated for this pain + suffering i experienced.This scar will never go away.I remove the wrap and my skin was burn, i was at work sitting at my desk when i felt a sting." the patient reported "i have a scar" on (b)(6) 2017 and did not receive treatment due to the event.The patient was not currently under the care of a physician for any medical condition.This device was not available for evaluation.The action taken with thermacare heatwraps was temporary withdrawn on (b)(6) 2017.The outcome of event burn/same size and shape of a heat cell, also compared it to a quarter was resolved in 2017.The outcomes of events skin completely come off and scar were not resolved.The outcomes of the other events were unknown.According to the reporting consumer the device was not available to be returned for evaluation.Additional information has been requested and will be provided as it becomes available.Follow-up (13apr2017): follow-up attempts are completed.No further information is expected.Follow-up (06jun2017): new information reported from the consumer includes: additional information on product (lot number and expiration date), patient did not previously used thermacare, and new event (scar).Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the reported events thermal burn, skin exfoliation, device use error, and intentional device misuse as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event "scar" is considered non serious and not associated with the use of the device.Comment: based on the information provided, the reported events thermal burn, skin exfoliation, device use error, and intentional device misuse as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event "scar" is considered non serious and not associated with the use of the device.
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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The thermal and pti data for the batch were reviewed and there were no thermal or leak results outside the required specifications.It¿s possible that a small pouch leak allowed air to get into the pouch and the wrap slowly activated.When the wrap was opened for use, the wrap has already utilized some of its heating ability, thus may not heat as long as designed.However; once the wrap is open there is no way to determine if a pouch leak was present.A review of the batch thermal data does not indicate any thermal issues associated with this batch.A complaint of heat did not last long enough is subjective and cannot be confirmed by the site.
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Event Description
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Event verbatim [preferred term] burn/same size and shape of a heat cell, also compared it to a quarter [thermal burn], the skin has completely come off [skin exfoliation], she did not check skin under the product while wearing [device use error], she did not check skin under the product while wearing.She read the usage instructions on thermacare before using the product [intentional device misuse], scar [scar].Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) black (other african american) not pregnant female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number: r44751, expiration date: sep2019) from (b)(6) 2017 at 1 wrap unknown frequency for cramps.Medical history included uterine leiomyoma that she was seeing an obgyn for uterine fibroids and would be having surgery for this soon, heartburn.The patient did not have diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis, decreased sensation and neuropathy.Concomitant medication included esomeprazole magnesium (nexium) at 40 mg, once a day for heartburn from 2016 and ongoing and ibuprofen at 400 mg, single for cramps from (b)(6) 2017 and ongoing.The patient did not previously used thermacare.The patient had previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) and did not experienced any problems.She stated she bought thermacare mentrual wraps a couple of days before the report.She wore it to work for might be 4 hours yesterday, (b)(6) 2017, and she had a burn on her stomach area.She attached the wrap to her underwear as the instructions suggested.Wore the wrap for 4 hours while at work.Stated that she was sitting in a chair for most of that time.The patient wore thermacare not long might be 4 hours, might be not more than 4.She wore the wrap for about 4 hours, and when she took it off, she noticed a burn.She still had an imprint of the heat cells all over her stomach where the wrap was, but there was only one spot on the left side that actually burned.The burn was the same size and shape of a heat cell, also compared it to a quarter.The skin had completely come off, and was now just a white spot.She did not feel that it was necessary to go to the doctor.She had been keeping the burn covered, and had been putting vaseline on it.She stated she might try to put some bacitracin, neomycin sulfate, polymyxin b sulfate (neosporin) on it to help bring the color back.The patient classified her skin tone as medium (neither light nor dark), stated that she was brown.The patient did not have sensitive skin or abnormal skin conditions.She had 2 unused wraps.Lot number and expiration date was unknown because she didn't have the product with her.She did not engage in exercise while using the product.She did not check skin under the product while wearing on (b)(6) 2017.The patient did have sensitive skin and did not have any abnormal skin conditions.The patient attached adhesive to clothing.She read the usage instructions on thermacare before using the product.She also complained the heat didn't usually last the full 8 hours.She stated she noticed this when she first started using the wraps.This was a long time ago, and she no longer had any of the product left to provide lot number, upc, or expiration date.The patient was not hospitalized due to event burn.The patient was hospitalized due to the skin had completely come off.The patient received over the counter (otc) treatment for event the skin had completely come off.The patient further reported "the burn healed, i do have pictures.But the scar was still there.I believe i should be compensated for this pain and suffering i experienced.This scar will never go away.I remove the wrap and my skin was burn, i was at work sitting at my desk when i felt a sting." the patient reported "i have a scar" on (b)(6) 2017 and did not receive treatment due to the event.The patient was not currently under the care of a physician for any medical condition.This device was not available for evaluation.The action taken with thermacare heatwraps was temporary withdrawn on (b)(6) 2017.The outcome of event burn/same size and shape of a heat cell, also compared it to a quarter was resolved in 2017.The outcomes of events skin completely come off and scar were not resolved.The outcomes of the other events were unknown.According to the reporting consumer the device was not available to be returned for evaluation.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The thermal and pti data for the batch were reviewed and there were no thermal or leak results outside the required specifications.It's possible that a small pouch leak allowed air to get into the pouch and the wrap slowly activated.When the wrap was opened for use, the wrap has already utilized some of its heating ability, thus may not heat as long as designed.However; once the wrap is open there is no way to determine if a pouch leak was present.A review of the batch thermal data does not indicate any thermal issues associated with this batch.A complaint of heat did not last long enough is subjective and cannot be confirmed by the site.Additional information has been requested and will be provided as it becomes available.Follow-up (13apr2017): follow-up attempts are completed.No further information is expected.Follow-up (06jun2017): new information reported from the consumer includes: additional information on product (lot number and expiration date), patient did not previously used thermacare, and new event (scar).Follow-up (21jul2017): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the reported events thermal burn, skin exfoliation, device use error, and intentional device misuse as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event "scar" is considered non serious and not associated with the use of the device.Comment: based on the information provided, the reported events thermal burn, skin exfoliation, device use error, and intentional device misuse as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event "scar" is considered non serious and not associated with the use of the device.
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