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| Lot Number L16854 |
| Device Problems
Insufficient Heating (1287); Device Dislodged or Dislocated (2923)
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| Patient Problems
Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
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Event Type
Injury
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Event Description
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Other ones he would literary got burned with them, there are scissors inside of them and they could burn him and leave a blister like burn [thermal burn].Other ones he would literary got burned with them, there are scissors inside of them and they could burn him and leave a blister like burn [blister].Thermacarc heat wrap lower back and hip he used them for his arm/ he use them every day since (b)(6) 2002 suppose to stick to it and he had to put tape on it to make sure that it stay [device misuse].They didn't get warm much/ they are falling, they don't get warm and they don't stay on [product quality issue].Case description: this is a spontaneous report from a contactable consumer.A (b)(6) male patient started to receive thermacare heatwrap (thermacare lower back and hip), device lot number l16854, expiration date jan 2018, via an unspecified route of administration from an unspecified date to an unspecified date for spinal cord nerve injury, makes his hands go cold.Consumer mentioned that he used them for his arm because he had spinal cord nerve injury, makes his hands go cold and so he had to have these thermals.Consumer mentioned that he was getting (b)(6) a month from his insurance company but now pfizer had changed the thermacare "you wrap it around and it's got like velcro that together and these new wraps just absolutely no good, they don't get warm enough, they won't stay, the velcro part just not hold, it came off" and he want to get back to the old style.The patient mentioned that he was disabled from automobile accident.Consumer mentioned that sometimes he do have osteoporosis and he do use it "about my back once in a while but on my upper shoulders as i said there are bunch of broken neck bones so it's up in the neck.Mostly around the shoulders and that's only on the arms and sometimes once in a while during point of time i put one my leg".Consumer mentioned that he started using thermacare heat wrap lower back and hip since may be 2002 or 2003, he use them every day since, and but he got tape as the velcro was suppose to stick to it and he had to put tape on it to make sure that it stay on and was still using thermacare heat wrap lower back and hip and stated that they are not as good as the other ones, they didn't get warm much, the other ones he would literary got burned with them, there are scissors inside of them and they could burn him and leave a blister like burn and he pop them with a needle and they go away but these won't even warm him and further mentioned that he told his doctors about the burn and stated that his hand was burned but he did not wanted to complaint about that part because that was when it was working good for him but these don't work good.Consumer mentioned that he did not take any treatment for burn.Consumer mentioned that the neurologist prescribed him thermacare lower back and hip for the spinal-cord injury and there were six broken neck bones and because of that "i cracked my hands and my legs drag behind when i try to walk, so i got spinal cord injury and so my hands are into pills all the time and it's just cold".Consumer mentioned since he started using since back in 2002-2003, he never stopped one day, every day he uses it.Consumer mentioned that six bones were broken on (b)(6) 2002 at this time he was not using thermacare.Consumer mentioned that he got them (thermacare lower back and hip) up but they are falling, they don't get warm and they don't stay on.The action taken for thermacare heatwrap was unknown.Additional information has been requested and will be provided as it becomes available.
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Manufacturer Narrative
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Company clinical evaluation comment based on the information provided, the events thermal burn and blister with device misuse as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.
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Manufacturer Narrative
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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.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.It is possible 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 warm 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 too cool is subjective and cannot be confirmed by the site.
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Event Description
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Other ones he would literary got burned with them, there are scissors inside of them and they could burn him and leave a blister like burn [thermal burn].Other ones he would literary got burned with them, there are scissors inside of them and they could burn him and leave a blister like burn [blister].Thermacare heat wrap lower back and hip he used them for his arm, suppose to stick to it and he had to put tape on it to make sure that it stayed [device misuse].They didn't get warm much/ they are falling, they don't get warm and they don't stay on [product quality issue] case description: this is a spontaneous report from a contactable consumer.A (b)(6) caucasian male patient started to receive thermacare heatwrap (thermacare lower back & hip) (lot #: l16854, expiration date: jan2018) from an unspecified date for peripheral coldness (reported as a spinal cord nerve injury makes his hands go cold).Medical history included spinal cord injury from an unknown date and unknown if ongoing , osteoporosis from an unknown date and unknown if ongoing , multiple fractures from (b)(6) 2002 to an unknown date up in the neck, mostly around the shoulders, only on the arms, road traffic accident from an unknown date and unknown if ongoing, disability from an unknown date and unknown if ongoing.Concomitant medications were not reported.On an unspecified date, the patient reported he was getting "(b)(6)" a month from his insurance company but now pfizer had changed the thermacare."you wrap it around and it's got like velcro that ties together and these new wraps are just absolutely no good.They don't get warm enough, they won't stay, the velcro part just won't hold, it came off".He wants to get back to the old style heatwrap.The patient mentioned he was disabled from an automobile accident.He stated sometimes he does have osteoporosis and he does use it "about my back once in a while but on my upper shoulders as i said there are a bunch of broken neck bones so it's up in the neck, mostly around the shoulders and that's only on the arms and sometimes once in a while during point of time i put one on my leg".The patient reported he started using the lower back and hip heatwrap since 2002 or 2003.He used them every day since, but had to get tape as the velcro was supposed to stick to it and he had to tape it to make sure it stayed on.The patient indicated he was still using thermacare heatwrap lower back and hip and stated that they are not as good as the other ones, they didn't get warm much, the other ones he would literary get burned with them.There are scissors inside of them and they could burn him and leave a blister like burn.He popped them with a needle and they go away but these won't even warm him.He further mentioned he told his doctors about the burn and stated that his hand was burned but he did not want to complain about that part because that was when it was working good for him, but these don't work good.No therapeutic measures were taken as a result of the burn.The patient mentioned the neurologist prescribed him these heatwraps for the spinal-cord injury and there were six broken neck bones and because of that "i cracked my hands and my legs drag behind when i try to walk, so i got spinal cord injury and so my hands are into pills all the time and it's just cold".The patient stated since he started using the heatwraps back in 2002 or 2003, he uses one a day every day.He has never stopped.The patient reported six bones were broken on (b)(6) 2002 at this time he was not using thermacare.He mentioned that he got them (thermacare lower back and hip) up but they are falling, they don't get warm and they don't stay on.Action taken with the suspect product was ongoing.Clinical outcome of the events was unknown.Additional information received from product quality complaint (pqc) group provided quality assurance (qa) investigation results.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.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.It is possible 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 warm 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 too cool is subjective and cannot be confirmed by the site.Additional information has been requested and will be provided as it becomes available.Follow-up (19aug2015): new information received from product quality complaints (pqc) group included: quality assurance (qa) investigation results.Company clinical evaluation comment based on the information provided, the events thermal burn and blister with device misuse as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events thermal burn and blister with device misuse as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.Evaluation summary: 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.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.It is possible 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 warm 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 too cool is subjective and cannot be confirmed by the site.
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