Device Problem
Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Date 01/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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According to the injecting physician, there were no issues on aseptic manipulation of the injection.It was considered that the septic arthritis was possibly related to artz dispo.Company comment: we are requesting further information on the case.All of product batches passed with the release test including the sterility test before the product release.It is therefore highly unlikely that the product quality was related to the septic arthritis.Manufacturer's causality assessment is determined as "not related".(b)(4).
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Event Description
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On (b)(6) 2019: a (b)(6) year-old female patient received an injection of artz dispo for left gonarthrosis.On (b)(6) 2019: she had septic arthritis.2019-unk - she was admitted and had an operation at another hospital.
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Event Description
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(b)(6) 2019 - a 58 year-old female patient received an injection of artz dispo for left gonarthrosis.(b)(6) 2019 - she had septic arthritis.2019-unk - she was admitted and had an operation at another hospital.Unk - she recovered.
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Manufacturer Narrative
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According to the injecting physician, there were no issues on aseptic manipulation of the injection.It was considered that the septic arthritis was possibly related to artz dispo.Company comment: this is a definitive report.The physician denies to provide further information.The outcome was changed "recovered " from "recovering".All of product batches passed with the release test including the sterility test before the product release.It is therefore highly unlikely that the product quality was related to the septic arthritis.Manufacturer's causality assessment is determined as "not related".We selected the code of 4316(appropriate term/code not available) for h.6 manufacturer evaluation conclusion code because the reported adverse event was not listed in the package insert and concerned lot number was not available.
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Search Alerts/Recalls
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