Device Problems
No Apparent Adverse Event (3189); Illegible Information (4050)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2021 |
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 patient stated there should be more videos on explaining how to use the purewick urine collection system.Also stated that it would be not easy for elderly people to understand.
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Manufacturer Narrative
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Per investigator evaluation, bd has determined that this mdr event is not reportable.The device was not returned.
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Event Description
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It was reported that patient stated there should be more videos on explaining how to use the purewick urine collection system.Also stated that it would not be easy for elderly people to understand.Per mail received on 11oct2021, patient want more videos on describing how to use the purewick system.
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Search Alerts/Recalls
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