Lot Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/01/2020 |
Event Type
Injury
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Event Description
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Diabetes [diabetes].No cartilage [cartilage disorder nos].Screwed up something in her knee [knee sprain].Case narrative: initial information received on 16-feb-2021 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a (b)(6) female patient who experienced diabetes, no cartilage and screwed up something in her knee, with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On the unknown date of (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, dosage, indication, frequency: unknown) for osteoarthritis.On the unknown date (b)(6) 2020, after the latency of approximately 6 months of initiating the treatment with hylan g-f 20, sodium hyaluronate, patient diagnosed with diabetes (diabetes mellitus).Due to which her healthcare professional instructed her to walk every day and with the help of synvisc she was able to walk 2 miles every day.On the unknown date of (b)(6) 2020, after the latency of 11 months, patient was doing water aerobics and had screwed up something in her knee (ligament sprain).She clarified that she irritated it in the pool when she twisted it in the wrong way.She stated that she had no cartilage (chondropathy).According to her patient added that synvisc let her do exercises that previously she was unable to do.Final diagnosis was diabetes, screwed up something in her knee and no cartilage.Action taken: not applicable for all the events.It was not reported if the patient received a corrective treatment.Outcome: unknown for all the events.
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Event Description
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Diabetes [diabetes].No cartilage [cartilage disorder nos].Screwed up something in her knee [knee sprain].Case narrative: initial information received on 16-feb-2021 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a 70 years old female patient who experienced diabetes, no cartilage and screwed up something in her knee, with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On the unknown date of (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate, injection liquid (solution) (strength: 16 mg/ 2 ml) (formulation, dosage, indication, frequency: unknown) for osteoarthritis.On the unknown date (b)(6) 2020, after the latency of approximately 6 months of initiating the treatment with hylan g-f 20, sodium hyaluronate, patient diagnosed with diabetes (diabetes mellitus, medically significant).Due to which her healthcare professional instructed her to walk every day and with the help of hylan g-f 20, sodium hyaluronate she was able to walk 2 miles every day.On the unknown date of (b)(6) 2020, after the latency of 11 months, patient was doing water aerobics and had screwed up something in her knee (ligament sprain).She clarified that she irritated it in the pool when she twisted it in the wrong way.She stated that she had no cartilage (chondropathy).According to patient hylan g-f 20, sodium hyaluronate let her do exercises that previously she was unable to do.Action taken: not applicable for all the events.It was not reported if the patient received a corrective treatment.Outcome: unknown for all the events.A product technical complaint was initiated with global ptc number 100144630 and the results for the same were pending.Additional information received on 16-feb-2021 from healthcare professional.Global ptc number, formulation and strength added.Narrative updated accordingly.
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Event Description
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Diabetes [diabetes].No cartilage [cartilage disorder nos].Screwed up something in her knee [knee sprain].Case narrative: initial information received on 16-feb-2021 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a 70 years old female patient who experienced diabetes, no cartilage and screwed up something in her knee, with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On the unknown date of (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate, injection liquid (solution) (strength: 16 mg/ 2 ml) (formulation, dosage, indication, frequency: unknown) for osteoarthritis.On the unknown date (b)(6) 2020, after the latency of approximately 6 months of initiating the treatment with hylan g-f 20, sodium hyaluronate, patient diagnosed with diabetes (diabetes mellitus, medically significant).Due to which her healthcare professional instructed her to walk every day and with the help of hylan g-f 20, sodium hyaluronate she was able to walk 2 miles every day.On the unknown date of (b)(6) 2020, after the latency of 11 months, patient was doing water aerobics and had screwed up something in her knee (ligament sprain).She clarified that she irritated it in the pool when she twisted it in the wrong way.She stated that she had no cartilage (chondropathy).According to patient hylan g-f 20, sodium hyaluronate let her do exercises that previously she was unable to do.Action taken: not applicable for all the events.It was not reported if the patient received a corrective treatment.Outcome: unknown for all the events.A product technical complaint (ptc) was initiated on 16-feb-2021 for synvisc (lot number unknown) with global ptc number 100144630.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi will continue to monitor adverse event to determine if a capa was required.Final investigation was completed on 03-aug-2021.Additional information received on 16-feb-2021 from healthcare professional.Global ptc number, formulation and strength added.Narrative updated accordingly.Additional information was received on 03-aug-2021 from the healthcare professional.Ptc results received and processed.Text amended accordingly.
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