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 wocn nurse and prescribed nystop powder.
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A batch record review indicates no discrepancies.The product was manufactured under the appropriate device specification.The crew requirements and responsibilities, process parameters, quality and in-process inspections, line operations, process troubleshooting and relevant documents to the process were run according to the appropriate process instructions.The process requirements results were documented in the product batch record.The product was packed and labeled under the appropriate packaging and labeling specification.The bulk item record was reviewed.The crew requirements and responsibilities, process parameters, quality and in-process inspections, line operations, process troubleshooting and relevant documents to the process were run according to the appropriate process instruction.The process requirements results were documented in the product batch record.No non-conformances, deviations or discrepancies were found during revision.No further action is required and this issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
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