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| Lot Number R54929 |
| Device Problem
Inadequate User Interface (2958)
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| Patient Problems
Abdominal Cramps (2543); Partial thickness (Second Degree) Burn (2694)
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| Event Date 04/04/2017 |
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Event Type
Injury
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Event Description
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Had a burn, it was a burn she had a big blisters [burns second degree] , she did not check her skin under the product while wearing thermacare/she did not read the usage instructions on thermacare before she used the product.[device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare menstrual) (device lot number r54929, expiration date oct2019, (b)(4)) from an unspecified date for menstrual cramps.Medical history was reported as no.Concomitant medication included ibuprofen 300 mg once a day.Consumer mentioned that she bought a thermacare heat wrap for menstrual and she used them every month because it helped her cramps.She used it at 9 o'clock in the morning of (b)(6) 2017 and on the same day when she went to take it off she had a burn.The first time she used it when they actually first came out.This was the first time she had ever got burn from the product.She knew it was a burn she had a big blisters.She did not have sensitive skin.She did not have any abnormal skin condition.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare.She did not read the usage instructions on thermacare before she used the product.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event "burn blister and she did not check her skin under the product while wearing thermacare.She did not read the usage instructions on thermacare before she used the product" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device., comment: based on the information provided, the event "burn blister and she did not check her skin under the product while wearing thermacare.She did not read the usage instructions on thermacare before she used the product" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] the blister had already popped/it was a burn she had a big blisters/ burn was located under belly in front [burns second degree], she did not check her skin under the product while wearing thermacare/ she did read the usage instructions on thermacare before you used the product [device use error], she did not check her skin under the product while wearing thermacare/ she did read the usage instructions on thermacare before you used the product [intentional device misuse], she had product on all day from 9am in the morning until 6:30pm/ she did read the usage instructions on thermacare before you used the product [intentional device use issue], felt a little irritation [skin irritation].Case narrative:this is a spontaneous report from a contactable consumer reporting for self.A (b)(6) female caucasian patient (pregnant: no) started to receive thermacare heatwrap (thermacare menstrual) (device lot number r54929, expiration date oct2019, ndc number: (b)(4), upc number: (b)(4), also reported that upc number: (b)(4)) from unknown date and ongoing applied in the morning for menstrual cramps as need heat to function.Medical history included gastritis when (b)(6) and pain hurt.Concomitant medication included ibuprofen 800 mg as needed when pain hurt, was second day, so she had taken one yesterday ((b)(6) 2017); lactobacillus acidophilus (acidophilus) capsule as needed when stomach bothered her, started using 2 years after food poisoning and ongoing; ulmus rubra (slippery elm) started using 3 months ago ((b)(6) 2017) and ongoing at 5 mg capsule twice a day for gastritis.Consumer mentioned she started using the product when they first came out and has not used product today (b)(6) 2017.She used them every month because it helped her menstrual cramps.She purchased the product yesterday morning ((b)(6) 2017), and put one on as soon as she got to work at 9 o'clock in the morning of (b)(6) 2017.On the same day when she got home, felt a little irritation thought it was the pad rubbing.When she had taken the wrap off at 6:30pm, noticed that the blister had already popped.This was the first time she had ever got burn from the product.She knew it was a burn she had a big blisters.She kept putting coconut oil on it and band - aid to cover it up so that it would not get rubbed and hurt.Burn was located under belly in front, size of a nickel.She said she would still use the product, as helped her to function at work.The patient classified her skin tone as fair.She did not have sensitive skin.She did not have any abnormal skin condition.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare because have never had to, it felt like something, but thought it was the long pad, thought it was the pad rubbing.The color of the box purchased was red box.She has not previously used other heat products for pain relief.While wearing thermacare, she was at work and wearing underwear and scrubs.Attached the adhesive to clothing.She had product on all day from 9am in the morning until 6:30pm.She did read the usage instructions on thermacare before you used the product (previously reported that she did not read the usage instructions).She has not seen healthcare provider.The action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the event "the blister had already popped/it was a burn she had a big blisters/ burn was located under belly in front" was not resolved and for the other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (05apr2017): new information received from the same contactable consumer includes: medical history, concomitant drugs, new events ("felt a little irritation" and "she had product on all day from 9am in the morning until 6:30pm/ she did read the usage instructions on thermacare before you used the product"), and data capture aid result for the event burn blister.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 blister , she did not check her skin under the product while wearing thermacare, she did not read the usage instructions on thermacare before she used the product" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and are assessed as associated with the use of the device.The other event skin irritation is assessed as associated with the device use., comment: based on the information provided, the events "burn blister , she did not check her skin under the product while wearing thermacare, she did not read the usage instructions on thermacare before she used the product" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and are assessed as associated with the use of the device.The other event skin irritation is assessed as associated with the device use.
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Event Description
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Event verbatim: the blister had already popped/it was a burn she had a big blisters/ burn was located under belly in front [burns second degree].She did not check her skin under the product while wearing thermacare/ she did read the usage instructions on thermacare before she used the product [device use error] , she did not check her skin under the product while wearing thermacare/ she did read the usage instructions on thermacare before she used the product [intentional device misuse], she had product on all day from 9am in the morning until 6:30pm/ she did read the usage instructions on thermacare before you used the product [intentional device use issue], felt a little irritation [skin irritation].Case narrative:this is a spontaneous report from a contactable consumer reporting for self.A (b)(6) female caucasian patient (pregnant: no) started to receive thermacare heatwrap (thermacare menstrual) (device lot number r54929, expiration date oct2019, ndc number: (b)(4), upc number: (b)(4), also reported that upc number: (b)(4)) from unknown date and ongoing applied in the morning for menstrual cramps as need heat to function.Medical history included gastritis when (b)(6) and pain hurt.Concomitant medication included ibuprofen 800 mg as needed when pain hurt, was second day, so she had taken one yesterday ((b)(6) 2017); lactobacillus acidophilus (acidophilus) capsule as needed when stomach bothered her, started using 2 years after food poisoning and ongoing; ulmus rubra (slippery elm) started using 3 months ago ((b)(6) 2017) and ongoing at 5 mg capsule twice a day for gastritis.Consumer mentioned she started using the product when they first came out and has not used product today (b)(6) 2017.She used them every month because it helped her menstrual cramps.She purchased the product yesterday morning ((b)(6) 2017), and put one on as soon as she got to work at 9 o'clock in the morning of (b)(6) 2017.On the same day when she got home, felt a little irritation thought it was the pad rubbing.When she had taken the wrap off at 6:30pm, noticed that the blister had already popped.This was the first time she had ever got burn from the product.She knew it was a burn she had a big blisters.She kept putting coconut oil on it and band - aid to cover it up so that it would not get rubbed and hurt.Burn was located under belly in front, size of a nickel.She said she would still use the product, as helped her to function at work.The patient classified her skin tone as fair.She did not have sensitive skin.She did not have any abnormal skin condition.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare because have never had to, it felt like something, but thought it was the long pad, thought it was the pad rubbing.The color of the box purchased was red box.She has not previously used other heat products for pain relief.While wearing thermacare, she was at work and wearing underwear and scrubs.Attached the adhesive to clothing.She had product on all day from 9am in the morning until 6:30pm.She did read the usage instructions on thermacare before you used the product (previously reported that she did not read the usage instructions).She has not seen healthcare provider.The action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the event "the blister had already popped/it was a burn she had a big blisters/ burn was located under belly in front" was not resolved and for the other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (05apr2017): new information received from the same contactable consumer includes: medical history, concomitant drugs, new events ("felt a little irritation" and "she had product on all day from 9am in the morning until 6:30pm/ she did read the usage instructions on thermacare before you used the product"), and data capture aid result for the event burn blister.Additional information has been requested and will be provided as it becomes available.Follow-up (20apr2017): 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.Company clinical evaluation comment: based on the information provided, the events "burn blister , she did not check her skin under the product while wearing thermacare, she did not read the usage instructions on thermacare before she used the product" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and are assessed as associated with the use of the device.The other event skin irritation is assessed as associated with the device use., comment: based on the information provided, the events "burn blister , she did not check her skin under the product while wearing thermacare, she did not read the usage instructions on thermacare before she used the product" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and are assessed as associated with the use of the device.The other event skin irritation is assessed as associated with the device use.
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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed).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.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.
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Event Description
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Event verbatim [preferred term] the blister had already popped/it was a burn she had a big blisters/ burn was located under belly in front [burns second degree] , she did not check her skin under the product while wearing thermacare/ she did read the usage instructions on thermacare before you used the product [device use error] , she did not check her skin under the product while wearing thermacare/ she did read the usage instructions on thermacare before you used the product [intentional device misuse] , she had product on all day from 9am in the morning until 6:30pm/ she did read the usage instructions on thermacare before you used the product [intentional device use issue] , felt a little irritation [skin irritation] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for self.A (b)(6) patient (pregnant: no) started to receive thermacare heatwrap (thermacare menstrual) (device lot number r54929, expiration date oct2019, (b)(4)) from unknown date and ongoing applied in the morning for menstrual cramps as needed heat to function.Medical history included gastritis when (b)(6) and pain hurt.Concomitant medication included ibuprofen 800 mg as needed when pain hurt, was second day, so she had taken one yesterday ((b)(6) 2017); lactobacillus acidophilus (acidophilus) capsule as needed when stomach bothered her, started using 2 years after food poisoning and ongoing; ulmus rubra (slippery elm) started using 3 months ago ((b)(6) 2017) and ongoing at 5 mg capsule twice a day for gastritis.Consumer mentioned she started using the product when they first came out and has not used product today 05apr2017.She used them every month because it helped her menstrual cramps.She purchased the product yesterday morning ((b)(6) 2017), and put one on as soon as she got to work at 9 o'clock in the morning of (b)(6) 2017.On the same day when she got home, felt a little irritation thought it was the pad rubbing.When she had taken the wrap off at 6:30pm, noticed that the blister had already popped.This was the first time she had ever got burn from the product.She knew it was a burn she had a big blisters.She kept putting coconut oil on it and band - aid to cover it up so that it would not get rubbed and hurt.Burn was located under belly in front, size of a nickel.She said she would still use the product, as helped her to function at work.The patient classified her skin tone as fair.She did not have sensitive skin.She did not have any abnormal skin condition.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare because have never had to, it felt like something, but thought it was the long pad, thought it was the pad rubbing.The color of the box purchased was red box.She has not previously used other heat products for pain relief.While wearing thermacare, she was at work and wearing underwear and scrubs.Attached the adhesive to clothing.She had product on all day from 9am in the morning until 6:30pm.She did read the usage instructions on thermacare before you used the product (previously reported that she did not read the usage instructions).She has not seen healthcare provider.Action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the event "the blister had already popped/it was a burn she had a big blisters/ burn was located under belly in front" was not resolved and for the other events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).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.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.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2017): new information received from the same contactable consumer includes: medical history, concomitant drugs, new events ("felt a little irritation" and "she had product on all day from 9am in the morning until 6:30pm/ she did read the usage instructions on thermacare before you used the product"), and data capture aid result for the event burn blister.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2017): 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.Follow-up ((b)(6) 2017): 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 events "burn blister , she did not check her skin under the product while wearing thermacare, she did not read the usage instructions on thermacare before she used the product" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and are assessed as associated with the use of the device.The other event skin irritation is assessed as non-serious and associated with the device use., comment: based on the information provided, the events "burn blister , she did not check her skin under the product while wearing thermacare, she did not read the usage instructions on thermacare before she used the product" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and are assessed as associated with the use of the device.The other event skin irritation is assessed as non serious and associated with the device use.
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Search Alerts/Recalls
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