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, the catheter balloon did not deflate properly despite being emptied of saline.The issue occurred twice, and this time it caused trauma when it was pulled out by staff.The patient received unspecified treatment at the emergency room.
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