Model Number 35303 |
Device Problems
Nonstandard Device (1420); Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
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Event Description
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It was reported that the male external catheter had adhesion and retraction problem.
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Manufacturer Narrative
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Per investigator notification, it has been determined that this event is not reportable.The device was not returned.
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Event Description
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It was reported that the male external catheter had adhesion and retraction problem.
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Search Alerts/Recalls
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