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.Procedure: hip resurfacing.Date: (b)(6) 2021.Day post op reaction: (b)(6) 2021 (post op day 8).Current status: recovered.Id: nb male (b)(6) nkallergies, hip resurfacing on (b)(6) 2021, reaction: (b)(6) 2021 (8), photo, dressing: ch - to company directions, surgical prep-chlorhexidine 2% (red), dressing-no, mepilex border, nk allergies, sensitivity to adhesive no, yes patch tests, yes 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.Note: events reported on mw# 2210968-2022-01044.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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It was reported a patient underwent a hip arthroplasty/resurfacing 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 8, 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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