It was reported that after wearing the pod, the patient's skin has become irritated and rips off when is being removed.The patient visited the dermatologist on a scheduled appointment, has been diagnosed previously with atopic dermatitis, some more trauma has added to the skin, was prescribed steriod cream (ilocon) to apply twice a day and fatty moisturizer (linola fett) to apply 4 to 5 times a day to restore the integrity of the skin layer.
|
The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.We are unable to determine if any product condition could have contributed to the skin irritation.No lot release records were reviewed, as the product lot number was not provided.
|