Correction - contact office address: (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.Fda registration number reporting site: (b)(4).Manufacturing site: (b)(4).
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On (b)(6) 2021, the end user reported that she tried one wafer with pre-cut opening 25-mm but she stated that her stoma was also 25-mm and it rubbed against the wafer opening which she described as rough and she felt intermittent scratchiness.She could not say if the scratchiness was on the stoma or on the peristomal skin.No cuts, scrapes, or scratches was reported by end user.There was no leakage noted and the end user continued to use the product.No photo is available at this time.
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