Device Problem
Device Handling Problem (3265)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 03/30/2023 |
Event Type
Injury
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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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Event Description
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It was reported that latex allergy patient accidentally had a latex foley inserted in the pacu and developed a severe latex reaction.Foley was removed and replaced with a silicone catheter.Medical intervention was unknown.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.A potential root cause for this failure could be mishandling of device by user.The dhr review could not be performed without a lot number.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.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.
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Event Description
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It was reported that latex allergy patient accidentally had a latex foley inserted in the pacu and developed a severe latex reaction.Foley was removed and replaced with a silicone catheter.Medical intervention is unknown.
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Search Alerts/Recalls
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