Product complaint # (b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.(b)(4) patient 2 id: ct female (b)(6) nkallergies.Daa hip arthroplasty on (b)(6) 2021, reaction- (b)(6) 2021 (10), photo, dressing: ch - to company directions.Surgical prep:chlorhexidine 2% (red), dressing-no, nk allergies, yes sensitivity to adhesive, no patch tests, yes had previous exposure, yes used prineo/db, recovered.A manufacturing record evaluation was performed for the finished device batch and no non-conformances were identified.No product available for return.
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It was reported a patient underwent a hip arthroplasty on (b)(6) 2021 and topical skin adhesive was used.Patient had an allergic reaction to adhesive.Patient had reaction on (b)(6) 2021, post op day 10, and put on oral corticosteroids to manage the severe allergic reaction.Wounds not infected highly irritated rash associated with the dressing.Additional information has been requested.
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