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Device malfunction [device malfunction]; synovitis both knees [synovitis of knee]; difficulty exercising [exercise capacity decreased]; stiffness [joint stiffness]; more pain than expected [knee pain].Case narrative: this spontaneous case from united states was received on 10-may-2018 from physician.This case concerns (b)(6) patient of unknown gender who initiated treatment with synvisc one and after 2 days had more pain than expected; after an unknown latency had synovitis both knees, difficulty exercising and stiffness.A device malfunction was noted for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection (dose and indication: unknown) for osteoarthritis both knees (batch/ lot number: 7rsl021 and expiry date: may-2020).On (b)(6) 2017 after a latency of 2 days, patient had more pain than expected.On an unknown date in (b)(6) 2017 after an unknown latency, patient had difficulty exercising and stiffness.On an unknown date in 2017 the patient had synovitis in both knees.Corrective treatment: cortisone injections for synovitis both knees, difficulty exercising; medrol dosepak, cortisone injections for stiffness, more pain than expected.Outcome: unknown for all events.Seriousness criteria: required intervention for all events.An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.
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Device malfunction [device malfunction] difficulty exercising [exercise capacity decreased] synovitis both knees [synovitis of knee] stiffness [joint stiffness] more pain than expected/hip pain [knee pain] ([tenderness], [joint range of motion decreased]) gerd [gerd] post inflammatory hypopigmentation perioral area [post inflammatory hypopigmentation] tongue swelling [swelling of tongue] urticaria perioral [urticaria] weight is down for 100lbs [weight decreased] rash [rash] lip swelling [lip swelling] edema [edema] allergic reaction [allergic reaction] ([hives]).Case narrative: this spontaneous legal case from united states was received on (b)(6) 2018 from physician.This case concerns 35 years old patient of unknown gender who initiated treatment with synvisc one and after 2 days had more pain than expected; after an unknown latency had device malfunction, difficulty exercising, synovitis both knees, stiffness, more pain than expected/hip pain, gerd, post inflammatory hypopigmentation perioral area, tongue swelling, urticaria perioral, weight is down for 100lbs, rash, lip swelling and allergic reaction.The patient's past medical history included back pain, chronic spontaneous urticaria, arthralgia with left knee pain, road traffic accident in 2000, essential hypertension, knee operation, female sterilization, drug hypersensitivity with indernal (propranolol), asthma, migraine, ear pain, nausea, vision blurred, phonophobia, photophobia,fall, dysmenorrhea, edema, headaches, dysfunctional uterine bleeding, urinary incontinence and morbid obesity.Her family history included hypertension and migraine with father and hypertension with mother.Her past medical treatment(s), vaccination(s) was not provided.Concomitant medications included crisaborole (eucrisa), omalizumab (omalizumab), famotidine (pepcid), trospium chloride (sanctura), buspirone hydrochloride (buspar), promethazine (phenargun) for nausea, hydrochlorothiazide (hydrodiuril), hydroxyzine (atarax), diclofenac sodium (pennsaid), topiramate (topamax), celecoxib (celebrex), cyclobenzaprine hydrochloride (flexeril), hydrocodone bitartrate, paracetamol (norco), sumatriptan (imitrex) and mirabegron (myrbetriq).On (b)(6) 2017, patient received treatment with intra articular synvisc one injection (dose and indication: unknown) for osteoarthritis both knees (batch/ lot number: 7rsl021 and expiry date: may-2020).On (b)(6) 2017 after a latency of 2 days, patient had more pain than expected.On an unknown date in (b)(6) 2017 after an unknown latency, patient had difficulty exercising and stiffness.On an unknown date in 2017 the patient had synovitis in both knees.On (b)(6) 2018, when patient presented into healthcare facility and she was observed with lip swelling and also had right hip pain.She had also lost 100 lbs.She was observed with rash.On (b)(6) 2018, patient went to medical care facility and it was observed that the patient's weight was down over 100 lbs.On (b)(6) 2018, patient presented with urticaria perioral, arms and chest as well as tongue swelling.She also had hypertension at that time.On (b)(6) 2018, when patient went to hospital and she was observed with gerd, allergic reaction and urticaria.She also had post inflammatory hypopigmentation perioral area.Corrective treatment: cortisone injections for synovitis both knees, difficulty exercising; medrol dosepak, cortisone injections for stiffness, more pain than expected, epiphen and benadryl for lip swelling, and depo-medrol for pain in right hip joint.Outcome: unknown for all events.Seriousness criteria: required intervention for difficulty exercising, synovitis both knees, stiffness and more pain than expected/hip pain.A product technical complaint was initiated on (b)(6) 2018 for synvisc one, batch number: 7rsl021, global ptc number (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Additional information was received on 31-may-2018.Global ptc number was added.No significant information received.Additional information was received on 20-nov-2018 from lawyer.Events of gerd, post inflammatory hypopigmentation perioral area, tongue swelling, urticaria perioral, weight is down for 100lbs, rash, lip swelling and allergic reaction.Concomitant medication added.Patient's past medical history was updated.Case was upgraded to legal case.Clinical course updated, and text amended accordingly.
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