Complaint reported by end user that due to an irregularity in the pouch film, her stoma developed 2 to 3 reddened blood dots in the position where the pouch film touches the stoma.The defect on the pouch film was noted as a marking or niche in the pouch film located on the inside of the pouch.According to the end user, there was no pain or medical intervention.She stated that the defects were noted prior to use on all pouches, however, she choose to use them anyway.The end user was advised to stop using the product.No further details have been provided.
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