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Model Number 18320 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Scar Tissue (2060); Skin Inflammation/ Irritation (4545); Contact Dermatitis (4546)
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Event Date 01/01/2022 |
Event Type
Injury
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Event Description
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It was reported that an allergic reaction due to the pod adhesive causing irritation, inflammation and scarring had occurred while wearing the pod.The patient visited the doctor and was diagnosed with allergic contact dermatitis.As treatment, the patient received topical steroids.
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Manufacturer Narrative
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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 allergic reaction.No lot release records were reviewed, as the product lot number was not provided.
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Search Alerts/Recalls
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