Product complaint # (b)(4).Date sent to the fda: 10/20/2020.H3 evaluation: received one unit of pc2227 in outer sterile package.We could not find foreign object during visual inspection of the sealed pouch, so we opened both pouches carefully.There was 5 mm long piece of hair inside the primary pouch.The hair was found under the label applied upon the primary pouch, which explains why it was difficult to detect the piece of hair when the pouch was closed.According to the shape of the hair, it could be eyelash or eyebrow.There was piece of human hair found inside the originally sealed pouch.The complaint is observed.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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