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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 09/21/2022 |
Event Type
Injury
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Event Description
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It was reported that the unspecified bd prefilled saline syringe was involved with an adverse event, without an identified device malfunction/defect.The patient reported experiencing a severe reaction, including low blood pressure, lipothymia, closed throat, and convulsive movements.The following information was provided by the initial reporter: i still react very poorly to the product, which is a very common product that is used in many different situations, and therefore easy to miss when i am admitted in the hospital.I know i can¿t be allergic to nacl, but it must be something else.My reactions are as follows: * low blood pressure and lipotymia.* turns the eyes back in the head so only the white shows.* alienation of the body ¿ feeling.* all my joints and muscles stretch out, so i can¿t bend anything, but just lie like a stiff board.* red rash on the arm that has been injected.* my throat closes up.* convulsive movements.
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the unspecified bd prefilled saline syringe was involved with an adverse event, without an identified device malfunction/defect.The patient reported experiencing a severe reaction, including low blood pressure, lipothymia, closed throat, and convulsive movements.The following information was provided by the initial reporter: i still react very poorly to the product, which is a very common product that is used in many different situations, and therefore easy to miss when i am admitted in the hospital.I know i can¿t be allergic to nacl, but it must be something else.My reactions are as follows: low blood pressure and lipotymia.Turns the eyes back in the head so only the white shows.Alienation of the body ¿ feeling.All my joints and muscles stretch out, so i can¿t bend anything, but just lie like a stiff board.Red rash on the arm that has been injected.My throat closes up.Convulsive movements.
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Manufacturer Narrative
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H6: investigation summary.Per the provided feedback, we understand that this issue is not specific to a material number, lot number, or a sample; however, without such specifications, our investigative engineer team was unable to identify any potential manufacturing related causes for the reported reaction.Our investigative team is unable to relay the details of product composition.A device history review could not be completed as no batch number was provided.
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Search Alerts/Recalls
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