Model Number 509047 |
Device Problem
No Flow (2991)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Unometersafeti=110cm 1.5l rh (1/10pk)int.(b)(6).Based on the available information, this event is deemed a product malfunction.No patient harm was reported.Additional details have been requested but, not provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).
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Event Description
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It was reported that "the urine did not flow into the collection room" of the device.The device was removed.No further information was available.
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Manufacturer Narrative
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A batch record review was performed.A non-conformance is associated with this complaint, which is closed.The investigation concludes the likely root cause for the issue ¿stop flow between patient and chamber of unometer product¿ cannot be identified on the base of information received.No corrective action is required.No additional investigation is needed.This issue will be monitored through the post market product monitoring review process.No additional information has been provided to date.Should additional information become available, a follow up report will be submitted.
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Manufacturer Narrative
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The following fields have been corrected for supplemental 01, which was submitted on (b)(6) 2017.Patient id corrected from (b)(6) to (b)(6).Evaluation method code is correct on supplemental 01.Corrected evaluation method selection from manufacturing review c91960; fda 3317 - performing a review of manufacturing steps & processes to ensure that they were met & followed & that device records reflected these processes; to process evaluation c91978; fda 3331 - performing a review of manufacturing & production processes &/or records for a specific device or lot that may have contributed to problems with a device.No additional information has been provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).
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Search Alerts/Recalls
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