The root cause cannot be identified.The site investigated this complaint by reviewing the device history records and manufacturing controls.Thereview of the device history records, batch thermal records, and production controls met the product release criteria.Consumer reports " she received blisters after wearing the wrap".The cause of the consumer stating she received blisters is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of blisters or other skin irritations.This is an adverse event for blisters; a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
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On 12-aug-2022, a spontaneous report from the united states was received via telephone regarding a 30-year-old female who used a thermacare lower back and hip 8hr l/xl heat wrap.Medical history included an unspecified thyroid disorder and prior use of thermacare for years without event.Concomitant products included synthroid (levothyroxine).On (b)(6) 2022, the consumer topically applied a thermacare lower back and hip 8hr l/xl heat wrap to her lower abdomen because she should not find the menstrual cramp product.Six hours after wearing the product, she removed it and noticed that the site was red and irritated.The next morning, she noticed two painful blisters.She could line up the blister areas with the device.One blister was just right from the center that was the size of a half dollar.The other blister was just left of the center and the size of a nickel.Two days later the blisters ruptured.Her father, who was a physician, looked at the area.She stated she had a pretty bad second degree burn from the wrap.On (b)(6) 2022, she started treatment with prescription silvadene (silver sulfadiazine) applied to the area twice a day.She was instructed to wear loose fitted clothing to keep it from rubbing on the area.The area was deep and scabbed over after 2 days of treatment.It was healing but the larger blister area was concave.Both blister sites were red, pink, and painful.Her pain was a 3 out of 10.She felt the pain was a would healing type of pain.No additional information was provided.
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