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, complaint description: static anchor of altis was placed then dynamic anchor of altis was placed.Upon tensioning of dynamic anchor suture seemed to have broken away from mesh.Anchor on dynamic side remained in patient while mesh and suture were no longer attached.Status: product to remain at hospital for quality control, once i have contact information i will request an explant kit.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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