On 11-oct-2023, a spontaneous report from the united states was received via email regarding a female (age not provided) who used a thermacare lower back and hip heat wrap.On an unspecified date, the consumer topically applied a thermacare lower back and hip heat wrap for an unspecified indication.On an unspecified date, after applying the product, the consumer experienced "either a chemical burn or burn itself" and pain.No additional information was provided.
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The site investigated this complaint by reviewing the device history records and manufacturing controls.The review of the device history records, batch thermal records, and production controls met the product release criteria.Consumer reports a burn.The cause of the consumer a burn is inconclusive since review of records does not provide evidence to support defective product.There are pre-identified risk factors that could cause a burn listed in the hazard analysis (rpt-000097160).In addition to these hazards, there are multiple risks that are outside the control of the site.These include things like age, skin condition, medical conditions, device use error and off-label use.The warning labels on our product are used to address these risks and relay the appropriate instructions for use to our customers to avoid burns, blisters and skin irritations.This is an adverse event for a burn and a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
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