Catalog Number 05162645190 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).In general, post exposure management includes multiple consecutive steps such as: initial cleansing of the exposed area, defining the exposure and determination of (b)(6) status of the source of the exposure.Intact skin is an effective barrier against (b)(6) infection, and contamination of intact skin with blood or other potentially contaminated fluids is not considered an exposure and does not require post-exposure prophylaxis.
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Event Description
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The user accidentally spilled (b)(6) solution on her finger.The user was not wearing gloves; she washed her hands with soap and water.Product labeling states "however, as no inactivation or testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen." in this case, the user did not take the proper precautions.The user went to the doctor in the infectious diseases department where they considered the precicontrol hiv material to be potentially infectious.Diagnostic blood testing was performed but the results are not yet available.The user was prescribed and is currently taking 2 antiretroviral drugs: isentress (raltegravir) and truvada (emtricitabine / tenofovir).
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Manufacturer Narrative
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(b)(6) testing was performed on (b)(6) 2018 and the results were (b)(6).Following the (b)(6) results, the user stopped taking the antiretroviral drugs she had been prescribed.
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Search Alerts/Recalls
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