Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device, or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Device will not be returned.
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According to the available information, though not verified, initial implant in 2015.Patient has had difficulty pumping it in the last month.It wouldn't pump.Patient hears air bubbles.The physician drained and retained the old reservoir and placed a new reservoir.The physician noticed there was a leak to tubing to the right cylinder from the pump.Revision replaced cylinders and reservoir.Per the facility, device not being returned.
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