The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of (b)(6) 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as (b)(4).
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The physician reported, "some issues with the safetypexy fasteners.Specifically, the patient developed progressive erythema, induration, and some possible discharge.We ended up treating with keflex + mupirocin for cellulitis antibiotics were started on (b)(6)2021 after concerns was initially raised on (b)(6) 2021.
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