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| Lot Number M87693 |
| Device Problem
Temperature Problem (3022)
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| Patient Problems
Erythema (1840); Pain (1994); Tissue Breakdown (2681); Partial thickness (Second Degree) Burn (2694)
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| Event Date 08/22/2016 |
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Event Type
Injury
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Event Description
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Burnt her back [thermal burn]; two blisters [blister]; the magnet things on the pad got hot enough to form blisters/the product does not have adhesive [device issue]; did not check skin under the product while wearing thermacare [intentional device misuse]; painful [pain].Case description: this is a spontaneous report from a contactable consumer reported for herself.A (b)(6) caucasian female patient, not pregnant, no post-menopausal, started to receive thermacare heatwrap (thermacare lower back and hip) , device lot number m87693 01/08 , expiration date feb2018 , from 2014 and used (b)(6) 2016 for lower back pain, for (b)(6) 2016 kept it on her back for 8 hours with no problem.Medical history included high blood pressure from an unknown date and unknown if ongoing.Concomitant medication included ongoing valsartan/ hctz 160-12.5mg since 2014 once a day high blood pressure; ongoing aspirin 81mg once a day for heart health.She was wearing a tee-shirt while using the product on (b)(6) 2016.The product does not have adhesive but has velcro on it that she used to wrap around her body.The product burnt her back and caused two blisters.Noticed it after 6.5 hours.Put it on in the morning and noticed it around lunch time.One blister is open and the other blister is not open.It is spaced out where those heat pellets were.The blisters are red and raised.One blister is big and one is small.The blisters are painful.Did not consult a healthcare professional for the problem.States the magnet things on the pad got hot enough to form blisters.No investigation.Currently not under the care of a physician for any medical condition: plans to use neosporin to treat the blisters.Has not started using it yet.Did not have any of the following conditions: has no diabetes; no poor circulation; no heart disease; no difficulty feeling heat or pain on skin; no rheumatoid arthritis; no decreased sensation ; no neuropathy; patient had medium skin tone, had no sensitive skin; had no abnormal skin conditions; previously on (b)(6) 2016 used electric heating pad for 1-2 hours for pain relief, no problem.Did not engage in exercise while using the product; did not check skin under the product while wearing thermacare; her husband did not see the burn on her back this morning when he assisted her with putting it on.Before used the product, patient did not read the usage instructions this time, but she's pretty sure she had read the instructions the previous times she has used the product.Patient did not consider the event serious.Events were not resolved by the time of report.She has permanently stopped that particular pad.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment based on the information provided, the events thermal burn, blister, device issue, 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 other event pain is 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 thermal burn, blister, device issue, 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 other event pain is 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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Burnt her back, 2 painful dark red marks [thermal burn]; two blisters/open blister [blister]; the magnet things on the pad got hot enough to form blisters [device issue]; did not check skin under the product while wearing thermacare [intentional device misuse]; bled a little bit [haemorrhage]; painful [pain].Case description: this is a spontaneous report from a contactable consumer reported for herself.A (b)(6) caucasian female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: m87693, expiration date: dec2018) from an unspecified date in 2014 for lower back pain.Medical history included high blood pressure from an unknown date and unknown if ongoing.The patient reported she was not pregnant and not post-menopausal.Concomitant medication included ongoing valsartan/ hctz 160-12.5mg since an unspecified date in 2014 once a day for high blood pressure; ongoing aspirin 81mg once a day for heart health.On (b)(6) 2016, the patient reported she used the product on her back for 8 hours with no reported problems.On (b)(6) 2016, the patient put the product on in the morning and wore the product over a tee-shirt and the heatwrap burnt her lower back and caused two blisters.She noticed the burn and blisters after 6.5 hours (sometime around lunch).The patient stated the product does not have adhesive but has velcro on it that she used to wrap around her body.She reported one blister is open and the other blister is not open.It is spaced out where those heat pellets were.The blisters are red and raised.One blister is big and one is small and both are painful.She stated her husband did not see the burn on her back this morning before she used the heatwrap, when he assisted her with putting it on.She did not consult a healthcare professional for the problem.The patient stated the magnet things on the pad got hot enough to form blisters.She stated the burns bled a little bit and she had 2 painful dark red marks on her back.The burn was worse than what she had initially thought.No investigations were performed.The patient is not currently under the care of a physician for any medical condition.She stated she plans to use neosporin to treat the blisters, but has not started using it yet.The patient denied any of the following conditions: diabetes; poor circulation; heart disease; difficulty feeling heat or pain on skin; rheumatoid arthritis; decreased sensation; sensitive skin; abnormal skin conditions.The patient assessed her skin tone as medium.She previously used an electric heating pad for 1-2 hours for pain relief on (b)(6) 2016 with no reported problems.She did not engage in exercise while using the product.The patient did not check her skin under the product while wearing the heatwrap.The patient did not read the usage instructions this time, but she's pretty sure she had read the instructions the previous times she used the product.The patient did not consider the event serious.Action taken with the suspect product was permanently withdrawn on an unspecified date.Clinical outcome of the events was not resolved by the time of report.Additional information has been requested and will be provided as it becomes available.Follow-up (23aug2016): new information received from a contactable consumer includes: updated suspect product expiration date and reaction data (additional event of bleeding).Company clinical evaluation comment: based on the information provided, the events thermal burn, blister, device issue, 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 other events pain and bleeding 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 thermal burn, blister, device issue, 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 other events pain and bleeding 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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Manufacturer Narrative
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The root cause category is nonassignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.The product effect may vary with each individual.
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Event Description
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Burnt her back, 2 painful dark red marks [thermal burn]; two blisters/open blister [blister]; the magnet things on the pad got hot enough to form blisters [device issue]; did not check skin under the product while wearing thermacare [intentional device misuse]; bled a little bit [haemorrhage]; scar [scar].Case description: this is a spontaneous report from a contactable consumer reported for herself.A (b)(6) caucasian female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: m87693, expiration date: feb2018 (initially reported as dec2018)) from an unspecified date in 2014 for lower back pain.Medical history included high blood pressure from an unknown date and unknown if ongoing.The patient reported she was not pregnant and not post-menopausal.Concomitant medication included ongoing valsartan/ hctz 160-12.5mg since an unspecified date in 2014 once a day for high blood pressure; ongoing aspirin 81mg once a day for heart health.On 20aug2016, the patient reported she used the lower back and hip heatwrap on her back for 8 hours with no reported problems.On (b)(6) 2016, she stated she put the product on in the morning and wore the product over a t-shirt and the heatwrap burnt her lower back and caused two blisters.She noticed the burn and blisters after 6.5 hours (sometime around lunch).The patient stated the product does not have adhesive but has velcro on it that she used to wrap around her body.She reported one blister is open and the other blister is not open.The patient indicated the burn and blisters are spaced out where those heat pellets were.The blisters are red and raised, one blister is big and one is small and both are painful.She stated her husband did not see the burn on her back this morning before she used the heatwrap, when he assisted her with putting it on.She did not consult a healthcare professional for the problem.No hospitalization was required as a result of the events.The patient stated the magnet things on the pad got hot enough to form blisters.She stated the burns bled a little bit and she had 2 painful dark red marks on her back.The burn was worse than what she had initially thought.No investigations were performed.The patient was not under the care of a physician for any medical condition.She stated she plans to use neosporin to treat the blisters, but has not started using it yet.Upon receipt of follow-up information from the consumer on 03oct2016, the patient reported her back has a scar and the pain was awful for a week.The patient denied any of the following conditions: diabetes; poor circulation; heart disease; difficulty feeling heat or pain on skin; rheumatoid arthritis; decreased sensation; sensitive skin; abnormal skin conditions.The patient assessed her skin tone as medium.She previously used an electric heating pad for 1-2 hours for pain relief on (b)(6) 2016 with no reported problems.She did not engage in exercise while using the product.The patient did not check her skin under the product while wearing the heatwrap.The patient did not read the usage instructions this time, but she's pretty sure she had read the instructions the previous times she used the product.The patient did not consider the event serious.Action taken with the suspect product was permanently withdrawn on an unspecified date.Clinical outcome of the events was not resolved.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 and technical 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.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (23aug2016): new information received from a contactable consumer includes: updated suspect product expiration date and reaction data (additional event of bleeding).Follow-up (29sep2016): new information received from product quality complaints group includes: investigation result and updated expiration date.Follow-up (03oct2016): new information received from a contactable consumer includes: reaction data (additional event of scar) and no hospitalization required.Company clinical evaluation comment: based on the information provided, the events thermal burn, blister, device issue, 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 other events bleeding and scar are assessed as associated with the device use.No device malfunction has been identified.
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Manufacturer Narrative
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The root cause category is nonassignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.The product effect may vary with each individual.
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Event Description
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Burnt her back, 2 painful dark red marks/caused a burn/serious burn/burn was horribly painful [thermal burn].Two blisters/open blister.The magnet things on the pad got hot enough to form blisters [device issue].Did not check skin under the product while wearing thermacare.[intentional device misuse].Bled a little bit [haemorrhage].Scar/scar on her back./scar on my back.Case description: this is a spontaneous report from a contactable consumer reported for herself.A (b)(6) female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: m87693, expiration date: feb2018 (initially reported as dec2018)) from an unspecified date in 2014 for lower back pain.Medical history included high blood pressure from an unknown date and unknown if ongoing.The patient reported she was not pregnant and not post-menopausal.Concomitant medication included ongoing valsartan/ hctz 160-12.5mg since an unspecified date in 2014 once a day for high blood pressure; ongoing aspirin 81mg once a day for heart health.On (b)(6) 2016, the patient reported she used the lower back and hip heatwrap on her back for 8 hours with no reported problems.On (b)(6) 2016, she stated she put the product on in the morning and wore the product over a t-shirt and the heatwrap burnt her lower back and caused two blisters.She noticed the burn and blisters after 6.5 hours (sometime around lunch).The patient stated the product does not have adhesive but has velcro on it that she used to wrap around her body.She reported one blister is open and the other blister is not open.The patient indicated the burn and blisters are spaced out where those heat pellets were.The blisters are red and raised, one blister is big and one is small and both are painful.She stated her husband did not see the burn on her back this morning before she used the heatwrap, when he assisted her with putting it on.She did not consult a healthcare professional for the problem.No hospitalization was required as a result of the events.The patient stated the magnet things on the pad got hot enough to form blisters.She stated the burns bled a little bit and she had 2 painful dark red marks on her back.The burn was worse than what she had initially thought.No investigations were performed.The patient was not under the care of a physician for any medical condition.She stated she plans to use neosporin to treat the blisters, but has not started using it yet.Upon receipt of follow-up information from the consumer on 03oct2016, the patient reported her back has a scar and the pain was awful for a week.The patient denied any of the following conditions: diabetes; poor circulation; heart disease; difficulty feeling heat or pain on skin; rheumatoid arthritis; decreased sensation; sensitive skin; abnormal skin conditions.The patient assessed her skin tone as medium.She previously used an electric heating pad for 1-2 hours for pain relief on (b)(6) 2016 with no reported problems.She did not engage in exercise while using the product.The patient did not check her skin under the product while wearing the heatwrap.The patient did not read the usage instructions this time, but she's pretty sure she had read the instructions the previous times she used the product.The patient did not consider the event serious.Upon follow up she reported she had the actual heat wrap that burned her and the box it came out of.Action taken with the suspect product was permanently withdrawn on an unspecified date.Clinical outcome of the event burn was resolved on an unspecified date that the outcome for the remaining events was not resolved.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 and technical 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.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (23aug2016): new information received from a contactable consumer includes: updated suspect product expiration date and reaction data (additional event of bleeding).Follow-up (29sep2016): new information received from product quality complaints group includes: investigation result and updated expiration date.Follow-up (03oct2016): new information received from a contactable consumer includes: reaction data (additional event of scar) and no hospitalization required.Follow-up attempts are completed.No further information is expected.Follow-up (18nov2016): new information received from a contactable consumer included product data (the device is available for evaluation) and reaction data (outcome for the event burn).Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment based on the information provided, the events thermal burn, blister, device issue, 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 other events bleeding and scar are assessed as associated with the device use.No device malfunction has been identified.
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