The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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 available information, this device required revision due to neuropathy and infection.The patient could not feel her left leg after implant.She had a revision of the device in april 2022 to cut the two ends of the band to relax the device.Patient had another procedure in october 2022 for a partial ablation and explantation of the device.Patient has had kinesiology, osteopathy, magnetizer, hypnosis, medications for the pain.Patient has also had perineal mri and perineal ultrasound.
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