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 information 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, a leak occurred on a vesical 3-way catheter, during the replacement of the catheter, the balloon burst three times.It was unclear if three catheters had balloon bursts, or if a single balloon burst in three places.The patient underwent invasive intervention, and some lesion of cutaneous state following contact with urine.
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