Dr.(b)(6) submitted a report to the fda (mw5098741) in regards to an adverse event during his operation.Dr.(b)(6) stated in his report that a (b)(6) year old female with no prior medical history underwent a breast augmentation surgery, in which an inplant funnel (lot 062320) was used, on (b)(6) 2020.Days after the surgery, the patient reported a fever and began broad-spectrum antibiotics shortly after.She returned to the operating room in 2021 and dr.(b)(6) reported that she experienced drainage of brown murky fluid around both the left and right breast implants.Both implants were removed and the pockets were irrigated and closed.Proximate concepts followed up with dr.(b)(6) in an attempt to gain more information pertaining to the event.Dr.(b)(6) was able to provide the lab tests done on the patient.The culture failed to isolate any aerobic organisms or anaerobes, yielding a negative result.Proximate concepts performed a manufacturing record evaluation (mre), which concluded that all inplant funnel's in lot 062320 were manufactured in accordance with documented specifications and procedures.As a result of proximate concepts' investigation, the cause of the adverse event cannot be traced back to the inplant funnel.As such, this complaint will be closed.Manufacturer's reference number: (b)(4).
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