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 information received, most likely, the loss of the catheter tip was detected after the catheter was removed, during catheter change.During the procedure of catheter change, the tip was removed from the bladder (method so far unknown - i guess with a cystoscope - to be clarified) before the new catheter was inserted.The tip detached from the catheter while the patient was hospitalized possibly caused by the patient by unintentional pull of the catheter.The tip could be removed from the bladder by surgical intervention in (b)(6) 2015 within the same procedure.This happened at the intensive care unit - so the patients should have been under intensive care.
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