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When she cuts the wrap in the packet with scissors, she accidently cut the wrap itself [device use error] , the inside the cells fell out on her bed, she brushed them into the floor with her hand [accidental exposure to product] , thermacare lower back & hip on her legs for leg cramps [intentional device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer and from the product quality complaint group.A (b)(6) year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), lot number not available, expiration date feb2020, on her legs from an unspecified date, for leg cramps.Medical history included cholesterol : "the reason i have the leg cramps is because of my cholesterol medication.Cholesterol medications have a plant statin in them and that plant statin generally causes people to have leg cramps a lot of the time." concomitant medication included pitavastatin calcium (livalo) for cholesterol.The patient uses thermacare heatwraps on her legs for cramps caused by her cholesterol medicine and she said it really helps her cramp.But she says she has to use scissors to open the packets.Last night during the night (b)(6)2019), she opened the packet at 3:00 am and when she opened it with scissors, she accidently cut the wrap.When she cuts the wrap in the packet with scissors, she accidently cut the wrap itself.So, when she turned it upside down to let it fall out of the packet, iron powder, the inside the cells fell out on her bed, she brushed them into the floor with her hand then she cleaned it up and put her sheet in the washing machine."it was not any damage to me at all.I just took my hand and just kind of brushed it off the side of the bed and then i folded to get the sheets up and them put them in the laundry and i guess, i got it all up the carpet and then i went washed my hands with warm soapy water.I did not have to have any medical treatment, it hadn't got hot, so it did not cause me any problem at all.Now, the contents had not had time to get hot, and that's what i love about these heatwraps anyway.They don't get overly heated.There is just a right temperature and i can apply them to the backs of my leg and it does not burn, it does not bother me at all.They are wonderful for what i used them for." the patient had discarded the product, was put in the trash and it was the last one in the box.On (b)(6) 2019, the product quality complaint group included specified that the product was thermacare lower back & hip.The action taken with thermacare heatwrap in response to the events and the clinical outcome of the events were unknown at the time of the report.Additionally the product complaint group reported that complaints received at the site in the global complaint database related to non-defect will not be investigated in the global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to a non-defect issue.No additional investigation will be required for these complaints based on the following: released batches met specification criteria at the time of release.There is no severity assigned to a non-defect.Site sample status: not received.No trend was identified.Additional information has been requested and will be provided as it becomes available.Follow-up (b)(6) 2019): new information from the product quality complaint group included: specification that the product was thermacare lower back & hip.Additional information has been requested and will be provided as it becomes available.Follow-up (b)(6) 2019): follow-up attempts are completed.No further information is expected.Follow-up (b)(6) 2020): new information from the product quality complaint group included: investigation results.Company clinical evaluation comment: the patient reported that "when she cuts the wrap in the packet with scissors, she accidently cut the wrap itself" (device use error) and "the inside the cells fell out on her bed, she brushed them into the floor with her hand" (accidental exposure to product).These events have a theoretical risk to cause a potential serious injury from the leaky cells.The events device use error, accidental exposure to product and intentional device use issue are medically assessed as associated with the use of the device.No other adverse event such as burn was associated with the use of the device.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.In the case narrative, there is evidence of device use error which most likely contributed to this incident., comment: the patient reported that "when she cuts the wrap in the packet with scissors, she accidently cut the wrap itself" (device use error) and "the inside the cells fell out on her bed, she brushed them into the floor with her hand" (accidental exposure to product).These events have a theoretical risk to cause a potential serious injury from the leaky cells.The events device use error, accidental exposure to product and intentional device use issue are medically assessed as associated with the use of the device.No other adverse event such as burn was associated with the use of the device.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.In the case narrative, there is evidence of device use error which most likely contributed to this incident.
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