Unable to work [impaired work ability], mental distress [mental distress], carpal tunnel [carpal tunnel syndrome], pain [pain], severe swelling [swelling], had scar tissue on the radial nerve [injury to radial nerve], was given synvisc in hand, was approved for knees only [off label use of device].Case narrative: initial information was received on 08-jan-2021 regarding an unsolicited valid serious case from a patient via health authorities of united states under reference mw5097718.This case involves an adult patient (gender: unknown) who received medical device hylan g-f 20, sodium hyaluronate (synvisc) and was unable to work, had mental distress, carpal tunnel, pain, severe swelling, had scar tissue on the radial nerve and was given synvisc in hand, was approved for knees only (off label use of device).The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.On an unknown date, the patient received injection of synvisc (hylan g-f 20, sodium hyaluronate) in hand but was approved for knees only (off label use of device) (dose, frequency, route, indication, lot - unknown).Information on batch number was requested.The doctor that gave this treatment.On (b)(6) 2000, after unknown latency, the patient had severe swelling (swelling), pain and mental distress (emotional distress; medically significant) since.The doctor who gave synvisc in hand never took any tests or x-rays before treating the patient with synvisc.The patient had surgery to repair the hand and was blown off biomatrix inc.The patient wanted satisfaction.Since the treatment, the patient went to another doctor and he did the nerve test to show that the patient had carpal tunnel (carpal tunnel syndrome; medically significant) and needed some painful hardware removed.Also, the patient had scar tissue on the radial nerve (radial nerve injury).At the time of report, the patient was unable to work (impaired work ability; was leading to disability) and financial situation was not good.Relevant laboratory test results included: nerve conduction studies - on an unknown date: carpal tunnel, had scar tissue on the radial nerve.Action taken: not applicable for off label use of device; unknown for rest all events.It was reported the patient received a surgery/repair for carpal tunnel as corrective treatment.The patient outcome is reported not applicable for off label use of device, not recovered for unable to work, unknown for rest all events.A product technical complaint (ptc) was initiated on 08-jan-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.Follow up information received on 11-jan-2021 from other healthcare professional.Global ptc number added.Additional information was received on 22-jan-2021 from healthcare professional.Investigational results were added.Text amended accordingly.
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