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.
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According to the available information, though not verified, reported complaint per csr: pump on new device filled too soon.Original device cylinder and reservoir placement was not optimal.Improper size, implant not sitting far enough distal.Reservoir placement improper.Placed new cylinder set." device was removed/replaced.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.
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