Device 1 of 5.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.This complaint has been evaluated.No lot number is available.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.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
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The end user stated an issue where the edge of the flange on the pouches was very sharp and she was concerned someone might cut their finger on this edge.Reportedly, "like a papercut, from the flange edge where the wafer would be attached".She considered this edge to be very sharp.Leakage was not a concern with this issue.The products were used on patient and no harm was reported.No photo is available at this time.
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