It was reported a patient underwent a total robotic hysterectomy on (b)(6), 2023 and topical skin adhesive was used.4 portal incisions where adhesive was used for closure.She had a post op reaction the required an er visit 72 hours later and was given hydrocortisone cream and oral prednisone.2 days later she went to the dermatologist and was given 80 ml of kenalog im and a prescription for clobetasol.The wound is angry, red, weeping , and seems to be spreading.Additional information has been requested.
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Product complaint #: (b)(4).Additional information: component code: g07002 - device not returned.Additional information provided: she has follow up scheduled with the dermatologist on (b)(6) 2023 and her ob on (b)(6) 2023.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Does we have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? no product is available for return.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, or its employees that the report constitutes an admission that the product, ethicon, 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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