Model Number 0500316E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
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Event Date 03/22/2022 |
Event Type
Injury
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Event Description
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It was reported to fresenius that the patient experiences itching after completing hemodialysis (hd) treatment with the optiflux 160nre dialyzer.There is no serious injury, adverse event, or medical intervention required regarding the reported issue.The itching is the extent of the patient¿s reaction and they do not experience any additional symptoms.The patient also does not take any over-the-counter (otc) medication in order to address the allergic reaction.The patient has been switched to a non-fresenius brand dialyzer temporarily.The complaint sample is not available to be returned to the manufacturer for a physical evaluation.
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Manufacturer Narrative
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The plant and clinical investigations are in process.A supplemental mdr will be submitted upon completion of these activities.
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Event Description
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It was reported to fresenius that the patient experiences itching after completing hemodialysis (hd) treatment with the optiflux 160nre dialyzer.There is no serious injury, adverse event, or medical intervention required regarding the reported issue.The itching is the extent of the patient¿s reaction and they do not experience any additional symptoms.The patient also does not take any over-the-counter (otc) medication in order to address the allergic reaction.The complaint sample is not available to be returned to the manufacturer for a physical evaluation.
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Manufacturer Narrative
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Correction: upon further review, it was determined that the event reported on 1713747-2022-00148 was not a reportable event related to fmc products.Additional information was received from the user facility indicating there was no medical intervention or prescription change required following this dialyzer reaction.As there is no indication or allegation from the customer that the device did not operate as intended or cause or contribute to a patient injury, no further updates will be made on mfr 1713747-2022-00148.
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Event Description
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It was reported to fresenius that the patient experiences itching after completing hemodialysis (hd) treatment with the optiflux 160nre dialyzer.There is no serious injury, adverse event, or medical intervention required regarding the reported issue.The itching is the extent of the patient¿s reaction and they do not experience any additional symptoms.The patient also does not take any over-the-counter (otc) medication in order to address the allergic reaction.The complaint sample is not available to be returned to the manufacturer for a physical evaluation.
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Manufacturer Narrative
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Correction: upon further review, it was determined that the event reported on 1713747-2022-00148 was not a reportable event related to fmc products.Additional information was received from the user facility indicating there was no medical intervention or prescription change required following this dialyzer reaction.As there is no indication or allegation from the customer that the device did not operate as intended or cause or contribute to a patient injury, no further updates will be made on mfr 1713747-2022-00148.
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Search Alerts/Recalls
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