Model Number 022771 |
Device Problems
Difficult to Remove (1528); Material Too Rigid or Stiff (1544)
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Patient Problems
Erythema (1840); Skin Irritation (2076); Fungal Infection (2419)
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Event Type
Injury
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Manufacturer Narrative
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Based on the available information, this event is deemed to be a serious injury.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.
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Event Description
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The end user reported that the skin barrier is very stiff and brittle prior to use, and when used remains adhered to the skin.According to the end user, the barrier is then difficult to remove from the skin and leaves the skin red and irritated where the barrier was in contact with the skin.She was seen by the (b)(6) and prescribed nystop powder.
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Manufacturer Narrative
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No lot number is available therefore a detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.(b)(4).
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Search Alerts/Recalls
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