Following initial receipt of the user facility's report, belmont's sales representative arranged a call with hospital risk management and learned that cloth towels are inserted between the patient and the wrap, which is not in accordance with the instructions for use.The ifu provides the following warning statement: "warning: ensure that nothing comes between the patient's skin and the thermowrap" and also instructs the user: "when closing the thermowrap around the patient, ensure that it fits loosely.(there should be a finger's width space between the patient and the thermowrap)." belmont medical technologies scheduled a subsequent call with the hospital to obtain additional information about the incident.It was reported that the patient suffered "skin lesions" and not "burns" as initially reported.The serial number of the allon used during the incident was not documented.The hospital's internal testing of all 7 allon units at the facility revealed that none of the devices produced temperatures above 37.6 degrees c.Neither the allon nor the thermowrap involved in the incident has been returned to belmont for investigation, therefore we are unable to confirm whether there are any anomalies with the device.We are aware that there is an ongoing investigation at the hospital and will provide a supplemental report should additional information become available.
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Belmont medical technologies received an initial report from the hospital risk management/patient safety officer that the patient potentially sustained burns, limited to the left posterior arm and left hip/upper buttock area, which reportedly developed two days after surgical treatment.
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