(b)(4).This medwatch report is in response to receipt of maude event report: mw5084291.(b)(4).No patient, doctor or hospital contact was included in this report.Therefore, no follow-up information can be provided or performed.If the device or further details are received at a later date a supplemental medwatch will be sent.
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It was reported a patient underwent a mastectomy on (b)(6) 2017 and topical skin adhesive was used.It was reported the incision displayed chemical burns, blisters and a rash.Patient had excessive pain and inflammation.The incision was not healing from surgery and the incision was breaking down, resulting in the need for another surgery 2018.The device is not available for return.No further details may be obtained.
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