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Catalog Number CL1097P |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Purulent Discharge (1812); Post Operative Wound Infection (2446)
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Event Type
Injury
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Manufacturer Narrative
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This event is being reported as serious injury due to the reported infection and purulent discharge with surgical intervention.A review of the device history record for artia lot up200135 has been initiated.If any new, changed or corrected information is noted, a supplemental report will be submitted.This is a known potential adverse event addressed in the product labeling.Without relevant patient factors, a relationship between the artia and this event could not be determined.If additional information is made available, a supplemental report will be submitted.
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Event Description
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Healthcare professional reported via sales representative that patient "presented in the er over the weekend with swelling, tenderness, redness, discolored discharge in [their] axillary drain." "fluid tested positive for serratia bacteria." the two artia tissue grafts were explanted from the right breast.This record is for graft 1 of 2.This is the same event and the same patient reported under abbvie complaint # (b)(4).
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Search Alerts/Recalls
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