Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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According to the available information, the genesis malleable on right side was removed due to patient preference.It was reported that the device was placed in 2018, that the patient requested a 3 piece device to be implanted due to poor satisfaction with the single malleable device, and that there had been no complications from the malleable device.An inflatable prosthesis was implanted.
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