A1-a2: not provided.D4: catalog, serial, lot#: not provided & expiration date: not applicable.E1: reporter address: not provided.H4: manufacture date: not applicable.H10: a product sample was not returned to 3m for analysis.Without a sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to determine the root cause of the alleged injury or whether the 3m¿ bair hugger¿ warming unit was the root cause.The device labeling shall be reviewed for important contraindications, warnings, and cautions.
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A female allegedly underwent surgery on (b)(6)2023 at the (b)(6) center and experienced an injury noted as a left wrist 1st degree burn, blister, redness with severe pain that reportedly healed after approximately one month with the use of the 3m¿ bair hugger¿ warming unit.In pre-op, the nurse placed the 3m¿ bair hugger¿ warming unit on the left side of the bed.Postoperative, the patient felt a burning sensation at her left arm which she showed to the nurse who reportedly stated, "might have just lean over her arm during the surgery" and applied a cold pack on the patient's left arm.The patient went home, removed the cold pack, and observed blisters.The patient noted she thought the cold pack caused more blistering which reportedly did not look good, and presented to urgent care.The physician diagnosed the injury as a burn and prescribed a burning cream that reportedly did not help.The patient's current status noted the burn is dry, and the patient is applying scar cream to lighten up the dark scar.
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