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Model Number 18320 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
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Event Date 04/24/2023 |
Event Type
Injury
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Event Description
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It was reported that after wearing the pod between 37 and 48 hours, the site was red, irritated, itchy and swollen.The patient consulted the health care practitioner (hcp) at a routine visit and was prescribed cavilon spray to apply on the affected area.
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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 skin irritation.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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