Catalog Number 786600 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); Discomfort (2330)
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Event Date 02/28/2024 |
Event Type
malfunction
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Event Description
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Critical care physician reported in a pmcf that the patient experienced an adverse event directly attributable to the device "787624 - inlay optimatm ureteral stent with hydroglide¿ guidewire, 6.0 fr.X 24cm " and the patient experienced "pain or discomfort".This did not result in the patient injury requiring medical or surgical intervention.
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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 of 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 critical care physician reported in a pmcf that the patient experienced an adverse event directly attributable to the device "787624 - inlay optimatm ureteral stent with hydroglide¿ guidewire, 6.0 fr.X 24cm " and the patient experienced "pain or discomfort".This did not result in the patient injury requiring medical or surgical intervention.
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Search Alerts/Recalls
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