Lot Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Myalgia (2238); No Code Available (3191)
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Event Date 02/19/1999 |
Event Type
Injury
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Event Description
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Scratchy eyes [abnormal sensation in eye] myalgia [myalgia] flushing [flushing] given for serious injury [product use in unapproved indication] case narrative: this case is cross linked with case:(b)(4) (same patient, multiple devices).Initial information received on 08-jan-2021 regarding an unsolicited valid serious case from united states received from a physician.This case involves adult patient who experienced flushing, scratchy eyes, myalgia and given for serious injury, while he/she was treated with 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 an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection, (dosage, batch number, frequency: unknown) via intra-articular route for serious injury (product used for unknown indication).On (b)(6) 1999, after the unknown latency of initiating the treatment with hylan g-f 20, sodium hyaluronate in left knee, patient had flushing, scratchy eyes (abnormal sensation in eye) and myalgia.Final diagnosis was myalgia, scratchy eyes, flushing and given for serious injury.Action taken: not applicable for given for serious injury; unknown for rest all the events.It was not reported if the patient received a corrective treatment.Outcome: not applicable for product used for unknown indication; unknown for rest all the events.A product technical complaint was initiated and results were pending for same.This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in (b)(4)and module vi of the good pharmacovigilance practices.
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Event Description
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Scratchy eyes [abnormal sensation in eye].Myalgia [myalgia].Flushing [flushing].Given for serious injury [product use in unapproved indication].Case narrative: this case is cross linked with case:(b)(6) (same patient, multiple devices).Initial information received on 08-jan-2021 regarding an unsolicited valid serious case from united states received from a physician.This case involves adult patient who experienced flushing, scratchy eyes, myalgia and given for serious injury, while he/she was treated with 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 an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection, (dosage, batch number, frequency: unknown) via intra-articular route for serious injury (product used for unknown indication).On (b)(6) 1999, after the unknown latency of initiating the treatment with hylan g-f 20, sodium hyaluronate in left knee, patient had flushing, scratchy eyes (abnormal sensation in eye) and myalgia.Final diagnosis was myalgia, scratchy eyes, flushing and given for serious injury.Action taken: not applicable for given for serious injury; unknown for rest all the events.It was not reported if the patient received a corrective treatment.Outcome: not applicable for product used for unknown indication; unknown for rest all the events.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc for unknown batch number and global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: 22-jan-2021.This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module vi of the good pharmacovigilance practices.The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.Follow-up was received on 08-jan-2021 from other healthcare professional.Global ptc number added.No significant information received.Additional information was received on 22-jan-2021 from other healthcare professional.Investigation results added.No significant information received.
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