Healthcare professional reported implantation of seri during a procedure to revise left side breast augmentation on (b)(6) 25014 conducted by the pt's previous physician.Post-operatively, the pt developed drainage from the incision which was treated with antibiotics.On (b)(6) 2015, the pt presented with multiple open wounds and exposure of the underlying seri scaffold mesh.At this time the physician performed excisional debridement and removal of the seri device.The device was discarded and will not be returned.The pt's symptoms resolved without sequelae.
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Further info from the reporter regarding event and product details has been requested.No add'l info is available at this time.The events of drainage and extrusion are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events.The physician discarded the device when it was explanted, and it is no longer available for return.Therefore, allergan will not receive the device and no analysis or testing will be done.These events are being reported because medical intervention was required, although device-relatedness has not been established.
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