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 of 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, when using the keith needle on the dacron pull suture - when you deploy it through the glans the dacron suture is frayed and fall to bits.This means you cannot locate the implant in the shaft.There appears to be no clinical consequences.The operation time was excessive, but coloplast has not been alerted to any infection or impaired function.
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