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Model Number AA61161002 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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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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Event Description
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According to available information, this device was not able to be used due to a tear.During the device preparation, at the opening of the peel pouch, the tip that must be inserted first in the urethra was torn without excessive traction applied to the tip.No other adverse patient effects were reported.
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Search Alerts/Recalls
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