Model Number PW100 |
Device Problems
Decrease in Suction (1146); Inadequate or Insufficient Training (1643)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/04/2023 |
Event Type
malfunction
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Event Description
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It was reported that the patient stated patient was having issues with the purewick urine collection system, patient did not know how to set it up.
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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.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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Event Description
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It was reported that the patient stated patient was having issues with the purewick urine collection system, patient did not know how to set it up.Per customer via phone 01june2023, the purewick does not have enough suction.Customer states they will call liberator for troubleshooting the next time they are about to use the device.No sample is available and no further follow up attempts will be made.
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Search Alerts/Recalls
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