It burns!! i have used muscle rubs/pain relief creams in the past, and have never had a problem/my skin was never red so there was no reaction, just got very hot/tingly [thermal burn], case narrative:this is a spontaneous report from a non-contactable consumer.This (b)(6) year-old female consumer started to receive thermacare heatwrap (thermacare heatwrap) from unknown date to unknown date for unknown indication.Medical history and concomitant medications were not reported.On (b)(6) 2018, the consumer stated, "it burns!! i have used muscle rubs/pain relief creams in the past, and have never had a problem.I have never had any skin allergies or reactions to anything, but boy did this stuff burn after being on me for a few minutes.It subsided after about 10-15 minutes, and my skin was never red so there was no reaction, just got very hot/tingly." consumer stated the product burnt significantly more.The action taken in response to the events of the product was unknown.The outcome of event was resolving.No follow-up attempts are possible.No further information is expected.Follow-up (14feb2018): this case is being submitted to notify that the initial information for this case was first received by the company on 14feb2018 and not on 15feb2018 as previously reported.Initial supplier to safety was updated to measurable supplier other.Follow-up (14feb2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the event thermal burn as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.Comment: based on the information provided, the event thermal burn as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
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