A batch record review for lot# 7a02383, was performed.The batch record review supports that there were no discrepancies during the manufacturing of lot 7a02383.A previous investigation is applicable to this complaint.The complaint/incidence data-post market analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints by the end user is a result of skin complications caused by a variety of external factors not related to the design, materials, and/or processes of the product.No further actions are required.Product monitoring reviews will monitor for product trends if this issue were to reoccur.Should additional information become available a follow-up report will be submitted.(b)(4).
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