The root cause cannot be identified.There was limited device-specific information provided, no batch number or return sample available for evaluation.Without a batch reference number, a manufacturing and technical assessment cannot be completed for the wrap involved in this case.No product quality-related trend was identified for the subclass adverse event safety request for investigation.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of burns.The manufacturing operations employ quality control procedures, including process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.
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On 31-oct-2022, a spontaneous report from the united states was received via email regarding a 68-year-old female consumer who used thermacare lower back & hip 8hr.Medical history included hypertension, seasonal allergies, and drug allergies to cefzil (cefprozil) and "sulfa" sulfonamides.The consumer reported that she had been using thermacare heat wraps for an unspecified number of years and loved them.Concomitant products included losartan, metoprolol, and other unspecified medications that the consumer declined to provide.On (b)(6) 2022, she applied a thermacare lower back & hip 8ct l/xl to her low back/hip area directly on her skin even though the label indicates to use a clothing barrier if above the age of 55.She noted she was recently burned.It was clarified that she left the heat wrap on for approximately nine to ten hours despite label instructions not to use longer than eight hours in a 24-hour period.When she later removed the wrap, she stated that the skin came off with the wrap which prompted her to look at the area.She noticed redness and skin peeling which she assumed was a deroofed blister.She reported that the area was painful and bled for a short amount of time.At the time of reporting, all symptoms are ongoing except for the bleeding.The consumer reported that no medical care had been sought and that she had been applying neosporin to the affected area.She denied the presence any signs or symptoms of infection.On 03-nov-2022 during a follow-up telephone call to the consumer, she noted that the pain had abated and that although there was some mild redness and peeling of the skin still present, the area was healing was healing.Consumer stated that she had not been evaluated by a medical provider as recommended.No further information was received after 03-nov-2022.
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