Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
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It was reported (via fda medwatch 5088031) that a female patient underwent a breast surgery procedure with mentor memorygel 400cc breast implants and experienced several unexplained systemic symptoms including blurry vision, dry eyes, brain fog, loss of memory, choking, eruptions on my face, dry skin, gum decay, hair loss, exhaustion, swollen lymph nodes, migraines, headaches, joint pain, back pain, breast pain, indigestion, insomnia and night sweats.No device issue such as rupture was reported, the root cause of the patient¿s symptoms is unclear.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report is for the left side.
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