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Model Number 00-1111-001-00 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Syncope (1610); Itching Sensation (1943); Rash (2033)
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Event Date 02/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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This case is received by seikagaku corporation on february 28, 2020 from the fda as mw5092945 dated february 24, 2020.We attempt to contact the reporter through our us partner.
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Event Description
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On (b)(6) 2020: a female patient received gel-one injection to the knee for osteoarthritis.Shortly following the injection at the md office, she fainted.She developed a severe itch and rash, and experienced chest pain.She was treated by emergency medical technicians and rushed to a hospital.On (b)(6) 2020: the patient was discharged with benadryl 50 mg.
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Manufacturer Narrative
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According to our us partner on may 12, 2020 no additional information was available in contact attempts on march 31, may 11.In the 2nd follow-up, the customer informed that they don't have additional information, hence the 3rd follow-up was not done.This case is received by seikagaku corporation on february 28, 2020 from the fda as mw5092945 dated february 24, 2020.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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Event Description
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(b)(6) 2020 - a female patient received gel-one injection to the knee for osteoarthritis.Shortly following the injection at the md office, she fainted.She developed a severe itch and rash, and experienced chest pain.She was treated by emergency medical technicians and rushed to a hospital.(b)(6) 2020 - the patient was discharged with benadryl 50 mg.
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Search Alerts/Recalls
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