COLOPLAST A/S VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH MALECOT CATHETER; UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE
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Catalog Number RMA114 |
Device Problem
No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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According to available information, this device required replacement due to a block.During indwelling, urine wouldn't flow through the device.No other adverse patient effects were reported.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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