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Reports she can not clean her house, too weak to drive, can't bend, can't play the piano, can't write, can't travel anymore and is almost home-ridden [activities of daily living impaired].Having stiffness like she has "never had in her life/ hands are even stiff [stiffness] didn't sleep at all that night [difficulty sleeping].Blood pressure was usually 110/68 but was 175/110 due to all the pain she was experiencing [blood pressure increased].Cannot bend her knees [joint range of motion decreased].Increased fatigue [fatigue aggravated].Sleep 22 hours [sleep excessive].Feel lousy, it blew up the energy [energy decreased].Reports she had swelling above knee down to ankle [swelling of legs].1000% worse than before [condition worsened].Constant pain in skeletal system [bone pain].Doesn't have any quality of life after getting these injections [quality of life decreased].Can't walk/can no longer walk up the steps [walking difficulty].Pain in hands [pain in hand].Severe flare up [joint inflammation] ([swelling of l knee], [aching (l) knee]) they felt chewed up inside/ feels like she has been struck by lightening [unevaluable event].Pain in hips, shoulders, elbows and ankles [joint pain].Synvisc one had not been approved for use with rheumatoid arthritis [device use in unapproved indication].Case narrative: based on the information received on 18-may-2020 the case was upgraded to serious as the event of she cannot clean her house, too weak to drive, can't bend can't play the piano, can't write, can't travel anymore and is almost home-ridden caused disability.This case was linked to case (b)(4) (same patient).Initial information received on 13-sep-2019 from united states regarding an unsolicited valid serious case received from a consumer.This case involves a (b)(6) years old female patient who experienced reports she cannot clean her house, too weak to drive, can't bend can't play the piano, can't write, can't travel anymore and is almost home-ridden, having stiffness like she has "never had in her life/ hands are even stiff, didn't sleep at all that night, blood pressure was usually 110/68 but was 175/110 due to all the pain she was experiencing, cannot bend her knees, increased fatigue, sleep 22 hours, feel lousy, it blew up the energy, had pain in hips, shoulders, elbows and ankles, pain in hand, reports she had swelling above knee down to ankle, constant pain in skeletal system, doesn't have any quality of life after getting these injections, can't walk/can no longer walk up the steps, severe flare up, they felt chewed up inside/ feels like she has been struck by lightning and synvisc one had not been approved for use with rheumatoid arthritis, 1000% worse than before, after she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included she was in a car accident years ago and had arthroscopic surgery on her left knee and feels that also has made her condition worse.Concurrent condition included had been walking with a walker since.The patient's past medical treatment included she had years ago her first hylan injection (doesn't know the name) 3 shots in both knees and tolerated it well, 2 years ago had synvisc-one and tolerated that well.Patient had vaccinations in 1944 as a child for prevention that caused her to have rheumatoid arthritis issues and she was not even going to take a flu shot and never has.The patient's concomitant medication and family history were not provided.On (b)(6) 2019, the patient started using hylan g-f 20, sodium hyaluronate, injection via intra-articular route, at dose of 6 ml (lot - unknown) for rheumatoid arthritis.Information on the batch number was requested.The patient was told by her nurse that synvisc one had not been approved for use with rheumatoid arthritis (latency: same day).On same day after the injection when she walked to the car and barely made it she was in so much pain and her knees started swelling immediately.Patient reported that she would have gone back in the office to tell them, but they were closed.Patient didn't sleep at all that night and by morning her knees were double in size.She contacted the doctor who told her that was caused by her rheumatoid arthritis and she never going to that doctor again and used to take oxycontin for pain when she had to stand all day in her job.On an unknown date in (b)(6) 2019, patient experienced a severe flare up (latency: unknown) after receiving the injection.On an unknown date in 2019, after unknown latency, patient reported that had ruined her summer since she can't walk, was in so much pain, her knees were in the worst pain, she felt they had chewed up inside (latency: unknown) she could not bend her knees and having stiffness like she had never had in her life and mentioned that the swelling was gone now but she still has the pain and her hands are even stiff since the last injection and she has trouble holding a fork and knife.Patient reported that her blood pressure was usually 110/68 but was 175/110 due to all the pain she was experiencing (latency: unknown), after she received the injection.The patient had not been able to get around due to the pain.On (b)(6) 2019, patient reported that she could no longer use the stairs and had to use an assist ride device for the stairs.Further, she reported she still had pain and her knees were still swollen.Patient reported that she could not walk or bend over.Patient felt 1000% worse than before (latency: unknown) had pain in hips, shoulders, hands, elbows and ankles (latency: unknown).She could not travel anymore and was almost home-ridden (latency: unknown; caused disability).Consumer had tried to contact lawyers and the fda but was unable to get answers due to covid-19.Consumer says she doesn't have any quality of life after getting these injections (latency: unknown).Patient experienced increased fatigue and felt like she has been struck by lightning (latency: unknown).Patient reported she cannot clean her house, was too weak to drive (latency: unknown) but was very independent prior to this.She said now she could sleep 22 hours (latency: unknown).Patient would like to know if there was slush fund for victims.She reports she had swelling above knee down to ankle (latency: unknown).She said she had constant pain in skeletal system (latency: unknown).She could not bend down, could not play the piano, could not write.She had to use chronic pain medication.Patient needed another steroid shot but cannot afford one and wanted to have a lawsuit because of this.Action taken: not applicable for all events corrective treatment: oxycodone hydrochloride (oxycontin) for so much pain in left knee; assist ride device for can't walk/can no longer walk up the steps; not reported for rest of the events.Outcome: not recovered for severe flare up; not applicable for synvisc one had not been approved for use with rheumatoid arthritis; unknown for rest of the events.A product technical was initiated on (b)(6) 2019 for synvisc one (lot number unknown) with global ptc number.The product lot number was not provided; therefore, a batch record review is 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 would continue to monitor adverse events to determine if a capa was required.The final investigation was completed on 23-sep-2019.Additional information was received on 23-sep-2019 from gemg.Ptc results received and processed.Global ptc number added.Additional information received on 17-oct-2019 from patient.Events of severe flare up, cannot bend her knees, they felt chewed up inside, blood pressure was usually 110/68 but was 175/110 due to all the pain she was experiencing and synvisc one had not been approved for use with rheumatoid arthritis.Event verbatim updated from so much pain in left knee/knees were in the worst pain to so much pain in left knee and can't walk to can't walk/can no longer walk up the steps.Outcome updated to not recovered for event of left knees started swelling immediately and were double in size.Events of so much pain in left knee/knees were in the worst pain and left knees started swelling immediately and were double in size updated to symptoms for event of severe flare up.Clinical course updated.Text amended accordingly.Additional information received on (b)(6) 2020 from the patient.Events of she cannot clean her house, too weak to drive, can't bend can't play the piano, can't write, can't travel anymore and is almost home-ridden, increased fatigue, sleep 22 hours, feel lousy, it blew up the energy, reports she had swelling above knee down to ankle, constant pain in skeletal system, doesn't have any quality of life after getting these injections, had pain in hips, shoulders, elbows and ankles, pain in hand and 1000% worse than before was added.Clinical course updated and text amended accordingly.
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