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, the patient experienced pain, hyperemia, ecchymosis, edema, and necrosis due to fungal infection.The patient underwent penile amputation surgery.
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