| Lot Number 7RSL021 |
| Device Problems
Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
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| Patient Problems
Cyst(s) (1800); Discomfort (2330); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)
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| Event Date 11/07/2017 |
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Event Type
Injury
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Event Description
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Based on additional information received on (b)(6) 2018, this case initially considered non serious was upgraded to serious as the serious events of device malfunction, wasn't able to move my leg, wasn't able to walk for weeks, severe pain with seriousness criteria as hospitalization/prolongation were added.This unsolicited case from united states was received on (b)(6) 2017 from other non health care professional this case concerns a (b)(6) female patient who received treatment with synvisc one injection and after few hours wasn't able to move leg, wasn't able to walk for weeks, had severe pain, took lots of fluid out of knee, could not bend knee, could not do any workout and after unknown latency experienced an adverse reaction.Also device malfunction was identified for the reported lot number.No past drug, concomitant medication and concurrent condition was provided.The patient had history of meniscus issue (for which doctor recommended that gel shot).The patient had no allergy.On (b)(6) 2017, the patient received treatment with intra- articular synvisc one injection (batch/lot number: 7rsl021, expiration date, dose, frequency: not provided) to lubricate knee.The same day, 2 hours after the patient got that shot, she wasn't able to move leg and had severe pain which ended up going to the hospital for two days.They took lots of fluid out of patient's knee and wasn't able to walk for two weeks.It was reported that more than a month the patient used a walker to get around t and was still in pain.The patient received treatment with hydrocodone-acetoin 7.5 and meloxicam 15 mg just for pain.On (b)(6) 2017, the patient saw the healthcare professional.She visited the emergency room and was admitted on the same day.On (b)(6) 2017, the patient was discharged.On an unknown date, after unknown latency experienced an adverse reaction.It was reported that the patient could not take any of those product (synvisc one) anymore and still had pain.The patient could not bend knee, could not sit on the floor and was not able to do any workout which she was able to do.Corrective treatment: walker for wasn't able to move my leg, wasn't able to walk for weeks; celecoxib (200 mg 1 capsule), ciprofloxacin (500 mg twice a day), hydrocodone acetaminophen (1 tablet a day) and meloxicam (15 mg; 1 tablet a day) for severe pain; not reported for other events outcome: unknown for experienced an adverse reaction; not recovered for rest of the 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 was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented seriousness criteria: hospitalization/prolongation for: device malfunction, wasn't able to move my leg, wasn't able to walk for weeks and severe pain additional information was received on (b)(6) 2018.Global ptc number and ptc results added.Text amended accordingly.Additional information was received on (b)(6) 2018 from the patient.This case initially considered non serious was upgraded to serious as the serious events of device malfunction, wasn't able to move my leg, wasn't able to walk for weeks, severe pain with seriousness criteria as hospitalization/prolongation were added.Also the event of can't bend knee, can't do any workout was added.The suspect product indication, batch/lot number and start date was added.The history of meniscus issue was added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 15-march-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later was hospitalized due to being unable to walk, having knee pain and knee effusion.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
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Event Description
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Device malfunction.Wasn't able to move my leg, wasn't able to walk for weeks/walking difficulty/ could not stand or walk/ gait asymmetric and abnormal stride length [unable to walk].Severe pain/knee pain/joint pain/stabbing, burning and throbbing pain/left knee pain/ pain became worse-sharp/aching/diffuse tenderness to palpation left knee/acute pain of left knee [knee pain] ([pain upon movement]).Took lots of fluid out of knee/supraptellar joint effusion.Swelling/joint swelling/ swelling in left knee/ l foot feels swollen.Can't bend knee, can't do any workout [joint range of motion decreased].Restricted weight bearing activity [weight bearing difficulty].Small posterior popliteal cyst [popliteal cyst].Leukocytosis [leukocytosis] ([wbc increased]).Tingling in left foot.Numbness in left foot.Plantar fascitis,bilateral [fascitis plantar].Bilateral carpel tunnel syndrome.Right and left foot pain.Pes planus of both feet [pes planus].Hysterical [unspecified].Hyperventilating.Glucose high.Mchc increased [mean cell hemoglobin concentration increased].Neutrophils high [neutrophil count increased].Immature granulocytes high [immature granulocyte count increased].Crp high [crp increased].Carbon dioxide low.Bloody color, cloudy synovial fluid left knee [synovial fluid analysis abnormal].Shoulder pain/r shoulder pain, when under stress l shoulder down into hand pain.([radiating pain]).Left knee have some locking [joint lock].Discomfort in her left knee [discomfort in joints].Left foot appeared swollen.Knee edema.No relief from synvisc one injection [device ineffective].Case narrative: based on additional information received on 27-jul-2018, the case was medically confirmed.Based on additional information received on 15-mar-2018, this case initially considered non-serious was upgraded to serious as the serious events of device malfunction, wasn't able to move my leg, wasn't able to walk for weeks, severe pain with seriousness criteria as hospitalization/prolongation were added.This unsolicited case from united states was received on 12-dec-2017 from other non health care professional.This case concerns a 42 years old female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) injection and methylprednisolone sodium succinate (solumedrol) and after few hours wasn't able to move leg, wasn't able to walk for weeks/walking difficulty, had severe pain/knee pain/joint pain/stabbing, burning and throbbing pain (latency: same day), could not bend knee, could not do any workout, after few days had restricted weight bearing difficulty (latency: unknown), small posterior popliteal cyst (latency: unknown), leukocytosis (latency: 1 day), tingling in left foot (latency: 1 day) , numbness in left foot (latency: 1 day), took lots of fluid out of knee/supraptellar joint effusion (latency: same day), left foot appeared swollen (latency: 2 days), knee edema (latency: unknown), no relief from synvisc one injection (device ineffective) (latency unknown), plantar fasciitis (latency: 2 months 15 days), bilateral carpel tunnel syndrome (latency: 2 months 15 days), right and left foot pain (latency: 2 months 15 days), pes planus of both feet (latency: 2 months 15 days) and pain with flexion and extension in left knee/sharp pain in left knee, hysterical, hyperventilating, glucose high (latency: 1 day 11 hrs), mchc increased (latency: 1 day 11 hrs), neutrophils high (latency: 1 day 11 hrs), immature granulocytes high (latency: 1 day 11 hrs), crp high (latency: 2 days), carbon dioxide low (latency: 1 day 11 hrs), bloody color, cloudy synovial fluid left knee (latency: 2 days), shoulder pain/r shoulder pain, when under stress l shoulder down into hand pain, left knee have some locking (latency: approx.9 months), discomfort in her left knee (latency: unknown).Also device malfunction was identified for the reported lot number.The patient had history of meniscus issue (for which doctor recommended that gel shot) and mild tri compartmental osteoarthritis at both knees, knee pain radiates into left buttock, posterior thigh and calf, all the way to heel, mild osteoarthritis left knee, aitered sensation in the l5-s1 dermatome distribution in the dorsolateral aspect of left foot, lower lumbar spine facet joint arthropathy, range of motion limited with flexion and extension lumbar spine, infection of knee, injury of meniscus of temporomandibular joint, injury of other muscles and tendons at lower leg level, left leg, venous insufficiency (bilateral) indicating varicose veins.The patient had no food, drug and environmental allergy.Patient was non-smoker.Patient had chest congestion, sore throat, arthralgia, knee pain as of (b)(6) 2017 (throbbing, sharp and burning pain- as of (b)(6) 2017), blood in urine, frequent headaches, abdominal pain, obesity since (b)(6) 2017, hysterectomy on (b)(6) 2016, knee pain described as popping, chronic and intermittent (problem alleviated by flexion and extension of the knee), had clicking, lower leg pain as of (b)(6) 2017, fall 6 years ago.Past medications included ibuprofen, ferrous sulfate, marcaine, zithromax and bactrim.Patient had not received synvisc one in the past.Patient denied any history of trauma to the knee and no recent trauma or falls.Patient had done physical therapy and had steroid injections without relief.Patient denied any personal or family history of rheumatoid arthritis, other inflammatory arthritis, or gout.No fevers, chills, or sweats.No prior history of pain, redness, or swelling in multiple joints.Family history included heart disease in mother and father.Concomitant medications included pantoprazole, meloxicam, docusate sodium (colace), heparin, ondansetron, ondansetron hydrochloride (zofran).On (b)(6) 2017, around 05:00 pm, the patient received treatment with intra- articular hylan g-f 20, sodium hyaluronate (synvisc one), injection, once (dose; unknown; batch/lot number: 7rsl021, expiration date: not provided) in left knee to lubricate knee, left knee after sterilizing the knee with betadine and alcohol swab.There were noted to be no adverse side effects or reactions.Pain was mild after the procedure, but after she attempted to go to bed (at 09:00 pm) pain became much worse.Patient described pain as sharp/aching radiates into her thigh with associated swelling.It was located in the anterior knee and worse with range of motion, palpation and weightbearing.Pain was so severe that she could not move her knee, stand or ambulate.The patient tried motrin, tramadol, ice, elevation without relief.The same day, she wasn't able to move leg and had increased severe pain and mild left knee swelling.There had been no associated fever.On the same day, patient was seen in emergency department at night and received intra muscular dilaudid with some relief and sent home with norco and crutches.Patient's pain was unrelenting at home.Patient had reaction to synvisc one and ended up needing drainage and hospital management for pain control for two days.On (b)(6) 2017, the patient saw the healthcare professional with intractable left knee pain following the injection, visited the emergency room again and was admitted on the same day.Patient was given iv pain medication which provided some relief and patient was feeling better.At this time orthopedics was consulted.On (b)(6) 2017, 1 day 11 hours after hylan g-f 20, sodium hyaluronate, patient was hysterical and hyperventilating and experiencing pain with any movement of the left-leg as well as light touch to the skin.Patient was able to flex and extend her toes and ankle although painful.Patient refused any examination secondary to the pain, although attempted initially.Wbc was elevated at 18.2, but the patient was afebrile and non toxic appearing.The left knee was swollen, but the patient denied any warmth or redness.It was reported that the flex and extend her toes and ankle although painful.On the same day, 1 day after hylan g-f 20, sodium hyaluronate, x-ray was negative for any acute osseous abnormality, but did noted a small joint effusion.Patient had left lower extremity venous and arterial duplex to rule out deep vein thrombosis or arterial occlusion which were unremarkable.On the same day, patient had ct of left knee/thigh and a small supra patellar left knee joint effusion was identified.Small posterior popliteal cyst was noted.The complete blood count with differential was performed 1 day after hylan g-f 20, sodium hyaluronate which revealed wbc 18.2 (high; ref-3.3-10.7 bil/l), mchc was 37 (high; ref: 32-35 g/dl), neutrophils were 16 (high;1.6-7.2 bil/l), immature granulocytes were 0.07 (high; 0-0.03 bil/l), glucose was 120 (high; 60-99 mg/dl), and 2 day after hylan g-f 20, sodium hyaluronate, crp was 7.3 (high; 0.0-0.8 mg/dl).As of (b)(6) 2017, patient had acute pain of left knee, leukocytosis and osteoarthritis of left knee, walking difficulty acute on chronic left knee pain with effusion.Patient's norco/dilaudid dose was increased to 7.5 mg, ice and elevated, prescribed toradol 30 mg once im and rest leg.On the same day, patient was given 4 mg zofran injection, 40 mg oral pantoprazole tablet.On (b)(6) 2017, 1 day after hylan g-f 20, sodium hyaluronate, patient had tingling and numbness in left foot, knee pain was 9/10 on pain scale and left foot appeared swollen.Edema was extra-articular and appeared to be a inflammatory reaction in quadriceps tendon/muscle, possibly due to extra articular injection of synvisc.It was reported that acute pain now could represent local inflammatory reaction or a pseudoseptic reaction to injection.The patient received treatment with hydrocodone-acetomin 7.5 and meloxicam 15 mg just for pain.On (b)(6) 2017, patient had aspiration of left knee and 30 ml of clear blood tinged synovial fluid was aspirated.Fluid analysis was negative for crystals or bacteria but was positive for 13000 wbc and 15000 rbc.Patient tolerated the procedure well.On the same day, wbc count increased to 24.1.Patient was still afebrile, despite an increase in wbc count, presumably thought to be from high dose of solu-medrol received in emergency department on arrival (dose, frequency and indication: unknown).Patient was appearing non toxic.Suspect leukocytosis was reactive but could not rule out septic arthritis.There was no sign of infection or compartment syndrome.Her left knee pain was improved and her range of motion also improved and the patient was able to ambulate with walker.Patient would be discharged with crutches, pain medication and rice therapy.Patient was cleared by orthopedic surgery for discharge home for outpatient follow up.On (b)(6) 2019, the patient had low carbon monoxide at 21, high glucose at 141, neutrophil count was 21.3 (high; 1.6-7.2 bil/l), monocytes were 1.1 (high; ref: 0-0.8 bil/l), immature granulocyte were 0.11 (high).On (b)(6) 2017, patient was discharged.More than a month patient used walker to get around.On an unknown date, after unknown latency experienced an adverse reaction.It was reported that the patient could not take any of those product (synvisc one) anymore and still had pain.The patient could not bend knee (latency: 1 day), could not sit on the floor and was not able to do any workout which she was able to do.On (b)(6) 2017, patient was reevaluated and reassessed for left knee.Patient complaint of constant stabbing, burning and throbbing pain in left knee.Patient had no relief from synvisc one injection.There was no signs of infection but she did had an effusion.Patient was aware that there was no evidence of infection from cultures taken at the hospital, cat scan taken at the hospital was normal, no evidence of abscess formation or damage to the quadriceps.Patient was able to single leg raise at this time indicating an intact extensor mechanism.On the same day, the left knee was aspirated of 35cc under sterile conditions.The patient tolerated the aspiration well and was aware to place an ice bag over the site tonight.The culture was sent for anaerobic, aerobic, gram stain, cell count and crystal analysis.Results were as follows: synovial fluid culture: no anaerobes recovered, gram stain: few poly morphonuclear cells (pmn's), moderate rbc's, no organisms, no growth at 4 days.Patient was given a prescription for a hinge brace.Patient would return for re-evaluation in 4 days.Patient's husband implied that the synvisc one injection was given directly into the quadriceps muscle, but there was no evidence of fluid or injury within the quadriceps.There was however evidence of fluid within the joint which was where the synvisc was injected.According to physician, this led to a reaction and this increased the production of fluid within her knee.Patient was advised to tell future doctors to never give her synvisc one because of this apparent reaction and was recommended that she should be given a brace prescription for her knee.On (b)(6) 2017, patient was reevaluated for left knee and still had pain in left knee.Patient was noted to have a moderate amount of effusion within the knee.No crepitation was noted beneath the kneecap with flexion and extension.Patient was discouraged from another aspiration and that the effusion appeared to be markedly reduced from the last aspiration.Patient was encouraged to perform rheumatologic testing to make certain there was not a rheumatologic cause for her continued complaints of pain.On (b)(6) 2017, patient presented with knee pain, location was on the left and at the joint line, described as tenderness and chronic.Symptoms were increasing.On an unknown date in (b)(6) 2017, after unknown latency, the complaint restricted weight bearing activity (intensity: moderate).As of (b)(6) 2017, patient complained of arthralgia, joint pain, joint swelling, knee pain and swelling.On the same day, patient's musculoskeletal examination showed that the gait was asymmetric and abnormal stride length.There was swelling in the left knee, tender joint line and pain with flexion and extension in left knee.On an unknown date in (b)(6) 2017, patient's white blood cell count was elevated.On (b)(6) 2017, patient complaint of sharp pain in left knee.There was minimal restricted range of motion.Physician could not feel any significant effusion nor was there erythema in the knee.On the same day, an aspiration was attempted in the left knee under sterile conditions, but were unable to aspirate any fluid to send for culture.The patient tolerated the aspiration well and was aware to place an ice bag over the site tonight.Patient was given a prescription for ciprofloxacin.On (b)(6) 2018, 2 months 15 days day after hylan g-f 20, sodium hyaluronate patient was diagnosed with primary osteoarthritis of left knee, plantar fasciitis, bilateral, bilateral carpel tunnel syndrome right and left foot pain and pes planus of both feet.Patient was taking non steroidal anti-inflammatory drugs (nsaid's) for pain.On (b)(6) 2018, patient presented for reevaluation to exclude an inflammatory arthritis.Patient was told that it was some kind of infection and was given antibiotics that cleared her elevated white count and it was now normal.Patient's left knee still hurts, pain in both hands was carpel tunnel syndrome and patient had flat feet and planar fasciitis being treated by podiatry.Patient had no evidence of inflammatory arthritis such as rheumatoid arthritis at this point.Patient was to wear splints in the evening and was also given a new prescription for carpal tunnel splints.The seriousness criteria of hospitalization/prolongation for device malfunction, wasn't able to move my leg, wasn't able to walk for weeks and severe pain and disability for wasn't able to move my leg, wasn't able to walk for weeks/walking difficulty/ could not stand or walk/ gait asymmetric and abnormal stride length, device malfunction, intervention required for severe pain/knee pain/joint pain/stabbing, burning and throbbing pain/left knee pain/ pain became worse-sharp/aching/diffuse tenderness to palpation left knee/acute pain of left knee.On (b)(6) 2018, the patient presented to physician with left knee knee pain with unchanged symptoms, shoulder pain, when under stress l shoulder down into hand pain and numbness.It was described as du11 numbness and tenderness.The review of musculoskeletal system revealed arthralgia, myalgias, decreased range of motions, hand pain, paraesthesia but denied muscle weakness.On (b)(6) 2018, the patient had left knee pain on a visual analog scale with 10 being the highest, the patient rated it as between 5-10.The pain was lateral and going down the leg.The patient also had some locking and had more difficulty descending than ascending the stairs.It was reported that the symptoms were relieved if the patient lied down ang got off her leg.The gram stain showed no growth and culture also showed no growth.Corrective treatment: walker for wasn't able to move my leg, wasn't able to walk for weeks; celecoxib (200 mg 1 capsule), ciprofloxacin (500 mg twice a day), hydrocodone acetaminophen (1 tablet a day) and meloxicam (15 mg; 1 tablet a day), hydrocodone bitartarate, paracetamol (norco), hydromorphone hydrochloride (dilaudid), tramadol and ibuprofen (motrin) for severe pain; not reported for rest of the events outcome: not recovered for gait inability, neutrophils high, glucose high, immature granulocytes high, device malfunction, arthralgia; recovering for can't bend knee, can't do any workout and recovered for mchc increased, unknown for rest of the events.A product technical complaint (ptc) was initiated on 25-jan-2018 for synvisc one.Batch number: 7rsl021; local ptc number: (b)(4); global ptc number: (b)(4).Returned: not available, date returned: investigation overview: 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 was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented additional information was received on 26-feb-2018.Global ptc number and ptc results added.Text amended accordingly.Additional information was received on 15-mar-2018 from the patient.This case initially considered non serious was upgraded to serious as the serious events of device malfunction, wasn't able to move my leg, wasn't able to walk for weeks, severe pain with seriousness criteria as hospitalization/prolongation were added.Also the event of can't bend knee, can't do any workout was added.The suspect product indication, batch/lot number and start date was added.The history of meniscus issue was added.Clinical course updated.Text was amended accordingly.Follow up was received on 04-apr-2018 from non-healthcare professional (attorney).No new information was added additional information was received on 19-jul-2018.Concomitant medications, medical history and past drugs were added.Event verbatim of experienced an adverse reaction/suffered injuries was updated and reporter causality for same was updated from unassessable to related.Text was amended accordingly.Additional information was received on 27-jul-2018 form a physician.The case was medically confirmed.Additional events of had restricted weight bearing difficulty, small posterior popliteal cyst, leukocytosis, tingling in left foot, numbness in left foot, left foot appeared swollen, knee edema, no relief from synvisc one injection (device ineffective), plantar fasciitis, bilateral, bilateral carpel tunnel syndrome, right and left foot pain, pes planus of both feet were added along with details.Event experienced an adverse reaction/suffered injuries was deleted.Event term wasn't able to move leg, wasn't able to walk for weeks was updated to wasn't able to move leg, wasn't able to walk for weeks/walking difficulty, severe pain was updated to severe pain/knee pain/joint pain/stabbing, burning and throbbing pain.Symptom pain with flexion and extension in left knee, swelling/joint swelling was added.Event took lots of fluid out of knee was updated as symptom of arthralgia.Additional suspect product solu-medrol was added along with details.Outcome of can't bend knee, can't do any workout was updated from not recovered to recovering.Clinical course was updated and text was amended accordingly.Additional information was received on 12-oct-2018 from other health professional.Investigation summary received as the case was updated to serious in previous version.Text amended accordingly.Additional information was received on 11-dec-2019 from lawyer.Event added for hysterical, hyperventilating, glucose high, mchc increased, neutrophils high, immature granulocytes high, crp high, carbon dioxide low, bloody color, cloudy synovial fluid left knee, shoulder pain/r shoulder pain, when under stress l shoulder down into hand pain, left knee have some locking, discomfort in her left knee.Medical history added.Labs added.Verbatim updated for took lots of fluid out of knee/supraptellar joint effusion.Event of took lots of fluid out of knee/supraptellar joint effusion updated from symptom to diagnosis, swelling/joint swelling/ swelling in left knee/ l foot feels swollen.Seriousness criteria of intervention required added for severe pain/knee pain/joint pain/stabbing, burning and throbbing pain/left knee pain/ pain became worse-sharp/aching/diffuse tenderness to palpation left knee/acute pain of left knee.Clinical course was updated.Text amended accordingly.
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Event Description
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Wasn't able to move my leg, wasn't able to walk for weeks/walking difficulty [unable to walk] device malfunction [device malfunction] severe pain/knee pain/joint pain/stabbing, burning and throbbing pain/left knee pain [knee pain] ([knee effusion], [joint swelling], [pain upon movement]) can't bend knee, can't do any workout [joint range of motion decreased] restricted weight bearing activity [weight bearing difficulty] small posterior popliteal cyst [popliteal cyst] leukocytosis [leukocytosis] ([wbc increased]) tingling in left foot [tingling] numbness in left foot [numbness in feet] left foot appeared swollen [swelling of feet] knee edema [edema knees] plantar fascitis,bilateral [fascitis plantar] bilateral carpel tunnel syndrome [carpal tunnel syndrome] right and left foot pain [foot pain] pes planus of both feet [pes planus] no relief from synvisc one injection [device ineffective] case narrative: based on additional information received on (b)(6) 2018, the case was medically confirmed.Based on additional information received on (b)(6) 2018, this case initially considered non-serious was upgraded to serious as the serious events of device malfunction, wasn't able to move my leg, wasn't able to walk for weeks, severe pain with seriousness criteria as hospitalization/prolongation were added.This unsolicited case from united states was received on (b)(6) 2017 from other non health care professional.This case concerns a 42 years old female patient who received treatment with synvisc one injection and methylprednisolone sodium succinate (solumedrol) and after few hours wasn't able to move leg, wasn't able to walk for weeks/walking difficulty, had severe pain/knee pain/joint pain/stabbing, burning and throbbing pain, could not bend knee, could not do any workout, after few days had restricted weight bearing difficulty, small posterior popliteal cyst, leukocytosis, tingling in left foot, numbness in left foot, left foot appeared swollen, knee edema, no relief from synvisc one injection (device ineffective), plantar fasciitis, bilateral, bilateral carpel tunnel syndrome, right and left foot pain, pes planus of both feet and pain with flexion and extension in left knee/sharp pain in left knee.Also device malfunction was identified for the reported lot number.The patient had history of meniscus issue (for which doctor recommended that gel shot) and mild tri compartmental osteoarthritis at both knees.The patient had no food, drug and environmental allergy.Patient was non-smoker.Patient had chest congestion, sore throat, arthralgia, knee pain as of (b)(6) 2017 (throbbing, sharp and burning pain- as of (b)(6) 2017), blood in urine, frequent headaches, abdominal pain, obesity since (b)(6) 2017, hysterectomy on (b)(6) 2016, knee pain described as popping, chronic and intermittent (problem alleviated by flexion and extension of the knee), had clicking, lower leg pain as of (b)(6) 2017, fall 6 years ago.Past medications included ibuprofen, ferrous sulfate, marcaine, zithromax and bactrim.Patient had not received synvisc one in the past.Patient denied any history of trauma to the knee and no recent trauma or falls.Patient had done physical therapy and had steroid injections without relief.Patient denied any personal or family history of rheumatoid arthritis, other inflammatory arthritis, or gout.No fevers, chills, or sweats.No prior history of pain, redness, or swelling in multiple joints.Family history included heart disease in mother and father.Concomitant medications included pantoprazole, meloxicam, docusate sodium (colace), heparin, ondansetron, ondansetron hydrochloride (zofran).On (b)(6) 2017, around 05:00 pm, the patient received treatment with intra- articular synvisc one injection, 1 df, once (batch/lot number: 7rsl021, expiration date: not provided) in left knee to lubricate knee, left knee after sterilizing the knee with betadine and alcohol swab.There were noted to be no adverse side effects or reactions.Pain was mild after the procedure, but after she attempted to go to bed (at 09:00 pm) pain became much worse.Patient described pain as sharp/aching radiates into her thigh with associated swelling.It was located in the anterior knee and worse with range of motion, palpation and weightbearing.Pain was so severe that she could not move her knee, stand or ambulate.The patient tried motrin, tramadol, ice, elevation without relief.The same day, she wasn't able to move leg and had increased severe pain and mild left knee swelling.There had been no associated fever.On the same day, patient was seen in emergency department at night and received intra muscular dilaudid with some relief and sent home with norco and crutches.Patient's pain was unrelenting at home.Patient had reaction to synvisc one and ended up needing drainage and hospital management for pain control for two days.On (b)(6) 2017, the patient with pain following the injection saw the healthcare professional, visited the emergency room again and was admitted on the same day.Patient was given iv pain medication which provided some relief and patient was feeling better.At this time orthopedics was consulted.Patient was hysterical and hyperventilating and experiencing pain with any movement of the left-leg as well as light touch to the skin.Patient was able to flex and extend her toes and ankle although painful.Patient refused any examination secondary to the pain, although attempted initially.Wbc was elevated at 18.2, but the patient was afebrile and non toxic appearing.The left knee was swollen, but the patient denied any warmth or redness.On the same day, x-ray was negative for any acute osseous abnormality, but did noted a small joint effusion.Patient had left lower extremity venous and arterial duplex to rule out deep vein thrombosis or arterial occlusion which were unremarkable.On the same day, patient had ct of left knee/thigh and a small supra patellar left knee joint effusion was identified.Small posterior popliteal cyst was noted.As of (b)(6) 2017, patient had acute pain of left knee, leukocytosis and osteoarthritis of left knee, walking difficulty acute on chronic left knee pain with effusion.Patient's norco/dilaudid dose was increased to 7.5 mg, ice and elevated, prescribed toradol 30 mg once im and rest leg.On the same day, patient was given 4 mg zofran injection, 40 mg oral pantoprazole tablet.On the same day, patient had tingling and numbness in left foot, knee pain was 9/10 on pain scale and left foot appeared swollen.Edema was extra-articular and appeared to be a inflammatory reaction in quadriceps tendon/muscle, possibly due to extra articular injection of synvisc.It was reported that acute pain now could represent local inflammatory reaction or a pseudoseptic reaction to injection.The patient received treatment with hydrocodone-acetomin 7.5 and meloxicam 15 mg just for pain.On (b)(6) 2017, patient had aspiration of left knee and 30 ml of clear blood tinged synovial fluid was aspirated.Fluid analysis was negative for crystals or bacteria but was positive for 13000 wbc and 15000 rbc.Patient tolerated the procedure well.On the same day, wbc count increased to 24.1.Patient was still afebrile, despite an increase in wbc count, presumably thought to be from high dose of solu-medrol received in emergency department on arrival (dose, frequency and indication: unknown).Patient was appearing non toxic.Suspect leukocytosis is reactive but could not rule out septic arthritis.There was no sign of infection or compartment syndrome.Her left knee pain improved and her range of motion also improved and she was able to ambulate with walker.Patient would be discharged with crutches, pain medication and rice therapy.Patient was cleared by orthopedic surgery for discharge home for outpatient follow up.On (b)(6) 2017, patient was discharged.More than a month patient used walker to get around.On an unknown date, after unknown latency experienced an adverse reaction.It was reported that the patient could not take any of those product (synvisc one) anymore and still had pain.The patient could not bend knee, could not sit on the floor and was not able to do any workout which she was able to do.On (b)(6) 2017, patient was reevaluated and reassessed for left knee.Patient complaint of constant stabbing, burning and throbbing pain in left knee.Patient had no relief from synvisc one injection.There was no signs of infection but she did had an effusion.Patient was aware that there was no evidence of infection from cultures taken at the hospital, cat scan taken at the hospital was normal, no evidence of abscess formation or damage to the quadriceps.Patient was able to single leg raise at this time indicating an intact extensor mechanism.On the same day, the left knee was aspirated of 35cc under sterile conditions.The patient tolerated the aspiration well and was aware to place an ice bag over the site tonight.The culture was sent for anaerobic, aerobic, gram stain, cell count and crystal analysis.Results were as follows: synovial fluid culture: no anaerobes recovered, gram stain: few poly morphonuclear cells (pmn's), moderate rbc's, no organisms, no growth at 4 days.Patient was given a prescription for a hinge brace.Patient would return for re-evaluation in 4 days.Patient's husband implied that the synvisc one injection was given directly into the quadriceps muscle, but there was no evidence of fluid or injury within the quadriceps.There was however evidence of fluid within the joint which was where the synvisc was injected.According to physician, this led to a reaction and this increased the production of fluid within her knee.Patient was advised to tell future doctors to never give her synvisc one because of this apparent reaction and was recommended that she should be given a brace prescription for her knee.On (b)(6) 2017, patient was reevaluated for left knee and still had pain in left knee.Patient was noted to have a moderate amount of effusion within the knee.No crepitation was noted beneath the kneecap with flexion and extension.Patient was discouraged from another aspiration and that the effusion appeared to be markedly reduced from the last aspiration.Patient was encouraged to perform rheumatologic testing to make certain there was not a rheumatologic cause for her continued complaints of pain.On (b)(6) 2017, patient presented with knee pain, location was on the left and at the joint line, described as tenderness and chronic.Symptoms were increasing.On an unknown date in (b)(6) 2017, the complaint restricted weight bearing activity (intensity: moderate).As of (b)(6) 2017, patient complained of arthralgia, joint pain, joint swelling, knee pain and swelling.On the same day, patient's musculoskeletal examination showed that the gait was asymmetric and abnormal stride length.There was swelling in the left knee, tender joint line and pain with flexion and extension in left knee.On an unknown date in (b)(6) 2017, patient's white blood cell count was elevated.On (b)(6) 2017, patient complaint of sharp pain in left knee.There was minimal restricted range of motion.Physician could not feel any significant effusion nor was there erythema in the knee.On the same day, an aspiration was attempted in the left knee under sterile conditions, but were unable to aspirate any fluid to send for culture.The patient tolerated the aspiration well and was aware to place an ice bag over the site tonight.Patient was given a prescription for ciprofloxacin.On (b)(6) 2018, patient was diagnosed with primary osteoarthritis of left knee, plantar fasciitis, bilateral, bilateral carpel tunnel syndrome right and left foot pain and pes planus of both feet.Patient was taking non steroidal anti-inflammatory drugs (nsaid's) for pain.On (b)(6) 2018, patient presented for reevaluation to exclude an inflammatory arthritis.Patient was told that it was some kind of infection and was given antibiotics that cleared her elevated white count and it was now normal.Patient's left knee still hurts, pain in both hands was carpel tunnel syndrome and patient had flat feet and planar fasciitis being treated by podiatry.Patient had no evidence of inflammatory arthritis such as rheumatoid arthritis at this point.Patient was to wear splints in the evening and was also given a new prescription for carpal tunnel splints.Corrective treatment: walker for wasn't able to move my leg, wasn't able to walk for weeks; celecoxib (200 mg 1 capsule), ciprofloxacin (500 mg twice a day), hydrocodone acetaminophen (1 tablet a day) and meloxicam (15 mg; 1 tablet a day), hydrocodone bitartarate, paracetamol (norco), hydromorphone hydrochloride (dilaudid), tramadol and ibuprofen (motrin) for severe pain; not reported for other events outcome: not recovered for gait inability, device malfunction, arthralgia; recovering for can't bend knee, can't do any workout and unknown for other 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 was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented seriousness criteria: hospitalization/prolongation for: device malfunction, wasn't able to move my leg, wasn't able to walk for weeks and severe pain additional information was received on (b)(6) 2018.Global ptc number and ptc results added.Text amended accordingly.Additional information was received on (b)(6) 2018 from the patient.This case initially considered non serious was upgraded to serious as the serious events of device malfunction, wasn't able to move my leg, wasn't able to walk for weeks, severe pain with seriousness criteria as hospitalization/prolongation were added.Also the event of can't bend knee, can't do any workout was added.The suspect product indication, batch/lot number and start date was added.The history of meniscus issue was added.Clinical course updated.Text was amended accordingly.Follow up was received on (b)(6) 2018 from non-healthcare professional (attorney).No new information was added additional information was received on (b)(6) 2018.Concomitant medications, medical history and past drugs were added.Event verbatim of experienced an adverse reaction/suffered injuries was updated and reporter causality for same was updated from unassessable to related.Text was amended accordingly.Additional information was received on (b)(6) 2018 form a physician.The case was medically confirmed.Additional events of had restricted weight bearing difficulty, small posterior popliteal cyst, leukocytosis, tingling in left foot, numbness in left foot, left foot appeared swollen, knee edema, no relief from synvisc one injection (device ineffective), plantar fasciitis, bilateral, bilateral carpel tunnel syndrome, right and left foot pain, pes planus of both feet were added along with details.Event experienced an adverse reaction/suffered injuries was deleted.Event term wasn't able to move leg, wasn't able to walk for weeks was updated to wasn't able to move leg, wasn't able to walk for weeks/walking difficulty, severe pain was updated to severe pain/knee pain/joint pain/stabbing, burning and throbbing pain.Symptom pain with flexion and extension in left knee, swelling/joint swelling was added.Event took lots of fluid out of knee was updated as symptom of arthralgia.Additional suspect product solu-medrol was added along with details.Outcome of can't bend knee, can't do any workout was updated from not recovered to recovering.Clinical course was updated and text was amended accordingly.
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Event Description
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Wasn't able to move my leg, wasn't able to walk for weeks/walking difficulty [unable to walk].Device malfunction [device malfunction.Severe pain/knee pain/joint pain/stabbing, burning and throbbing pain/left knee pain [knee pain] ([knee effusion], [joint swelling], [pain upon movement]).Can't bend knee, can't do any workout [joint range of motion decreased].Restricted weight bearing activity [weight bearing difficulty].Small posterior popliteal cyst [popliteal cyst].Leukocytosis [leukocytosis] ([wbc increased]).Tingling in left foot [tingling].Numbness in left foot [numbness in feet].Left foot appeared swollen [swelling of feet].Knee edema [edema knees].Plantar fascitis,bilateral [fascitis plantar].Bilateral carpel tunnel syndrome [carpal tunnel syndrome].Right and left foot pain [foot pain].Pes planus of both feet [pes planus].No relief from synvisc one injection [device ineffective].Case narrative: based on additional information received on 27-jul-2018, the case was medically confirmed.Based on additional information received on 15-mar-2018, this case initially considered non-serious was upgraded to serious as the serious events of device malfunction, wasn't able to move my leg, wasn't able to walk for weeks, severe pain with seriousness criteria as hospitalization/prolongation were added.This unsolicited case from united states was received on 12-dec-2017 from other non health care professional.This case concerns a 42 years old female patient who received treatment with synvisc one injection and methylprednisolone sodium succinate (solumedrol) and after few hours wasn't able to move leg, wasn't able to walk for weeks/walking difficulty, had severe pain/knee pain/joint pain/stabbing, burning and throbbing pain, could not bend knee, could not do any workout, after few days had restricted weight bearing difficulty, small posterior popliteal cyst, leukocytosis, tingling in left foot, numbness in left foot, left foot appeared swollen, knee edema, no relief from synvisc one injection (device ineffective), plantar fasciitis, bilateral, bilateral carpel tunnel syndrome, right and left foot pain, pes planus of both feet and pain with flexion and extension in left knee/sharp pain in left knee.Also device malfunction was identified for the reported lot number.The patient had history of meniscus issue (for which doctor recommended that gel shot) and mild tri compartmental osteoarthritis at both knees.The patient had no food, drug and environmental allergy.Patient was non-smoker.Patient had chest congestion, sore throat, arthralgia, knee pain as of (b)(6) 2017 (throbbing, sharp and burning pain- as of (b)(6) 2017), blood in urine, frequent headaches, abdominal pain, obesity since (b)(6) 2017, hysterectomy on (b)(6) 2016, knee pain described as popping, chronic and intermittent (problem alleviated by flexion and extension of the knee), had clicking, lower leg pain as of (b)(6) 2017, fall 6 years ago.Past medications included ibuprofen, ferrous sulfate, marcaine, zithromax and bactrim.Patient had not received synvisc one in the past.Patient denied any history of trauma to the knee and no recent trauma or falls.Patient had done physical therapy and had steroid injections without relief.Patient denied any personal or family history of rheumatoid arthritis, other inflammatory arthritis, or gout.No fevers, chills, or sweats.No prior history of pain, redness, or swelling in multiple joints.Family history included heart disease in mother and father.Concomitant medications included pantoprazole, meloxicam, docusate sodium (colace), heparin, ondansetron, ondansetron hydrochloride (zofran).On (b)(6) 2017, around 05:00 pm, the patient received treatment with intra- articular synvisc one injection, 1 df, once (batch/lot number: 7rsl021, expiration date: not provided) in left knee to lubricate knee, left knee after sterilizing the knee with betadine and alcohol swab.There were noted to be no adverse side effects or reactions.Pain was mild after the procedure, but after she attempted to go to bed (at 09:00 pm) pain became much worse.Patient described pain as sharp/aching radiates into her thigh with associated swelling.It was located in the anterior knee and worse with range of motion, palpation and weightbearing.Pain was so severe that she could not move her knee, stand or ambulate.The patient tried motrin, tramadol, ice, elevation without relief.The same day, she wasn't able to move leg and had increased severe pain and mild left knee swelling.There had been no associated fever.On the same day, patient was seen in emergency department at night and received intra muscular dilaudid with some relief and sent home with norco and crutches.Patient's pain was unrelenting at home.Patient had reaction to synvisc one and ended up needing drainage and hospital management for pain control for two days.On (b)(6) 2017, the patient with pain following the injection saw the healthcare professional, visited the emergency room again and was admitted on the same day.Patient was given iv pain medication which provided some relief and patient was feeling better.At this time orthopedics was consulted.Patient was hysterical and hyperventilating and experiencing pain with any movement of the left-leg as well as light touch to the skin.Patient was able to flex and extend her toes and ankle although painful.Patient refused any examination secondary to the pain, although attempted initially.Wbc was elevated at 18.2, but the patient was afebrile and non toxic appearing.The left knee was swollen, but the patient denied any warmth or redness.On the same day, x-ray was negative for any acute osseous abnormality, but did noted a small joint effusion.Patient had left lower extremity venous and arterial duplex to rule out deep vein thrombosis or arterial occlusion which were unremarkable.On the same day, patient had ct of left knee/thigh and a small supra patellar left knee joint effusion was identified.Small posterior popliteal cyst was noted.As of (b)(6) 2017, patient had acute pain of left knee, leukocytosis and osteoarthritis of left knee, walking difficulty acute on chronic left knee pain with effusion.Patient's norco/dilaudid dose was increased to 7.5 mg, ice and elevated, prescribed toradol 30 mg once im and rest leg.On the same day, patient was given 4 mg zofran injection, 40 mg oral pantoprazole tablet.On the same day, patient had tingling and numbness in left foot, knee pain was 9/10 on pain scale and left foot appeared swollen.Edema was extra-articular and appeared to be a inflammatory reaction in quadriceps tendon/muscle, possibly due to extra articular injection of synvisc.It was reported that acute pain now could represent local inflammatory reaction or a pseudoseptic reaction to injection.The patient received treatment with hydrocodone-acetomin 7.5 and meloxicam 15 mg just for pain.On (b)(6) 2017, patient had aspiration of left knee and 30 ml of clear blood tinged synovial fluid was aspirated.Fluid analysis was negative for crystals or bacteria but was positive for 13000 wbc and 15000 rbc.Patient tolerated the procedure well.On the same day, wbc count increased to 24.1.Patient was still afebrile, despite an increase in wbc count, presumably thought to be from high dose of solu-medrol received in emergency department on arrival (dose, frequency and indication: unknown).Patient was appearing non toxic.Suspect leukocytosis is reactive but could not rule out septic arthritis.There was no sign of infection or compartment syndrome.Her left knee pain improved and her range of motion also improved and she was able to ambulate with walker.Patient would be discharged with crutches, pain medication and rice therapy.Patient was cleared by orthopedic surgery for discharge home for outpatient follow up.On (b)(6) 2017, patient was discharged.More than a month patient used walker to get around.On an unknown date, after unknown latency experienced an adverse reaction.It was reported that the patient could not take any of those product (synvisc one) anymore and still had pain.The patient could not bend knee, could not sit on the floor and was not able to do any workout which she was able to do.On (b)(6) 2017, patient was reevaluated and reassessed for left knee.Patient complaint of constant stabbing, burning and throbbing pain in left knee.Patient had no relief from synvisc one injection.There was no signs of infection but she did had an effusion.Patient was aware that there was no evidence of infection from cultures taken at the hospital, cat scan taken at the hospital was normal, no evidence of abscess formation or damage to the quadriceps.Patient was able to single leg raise at this time indicating an intact extensor mechanism.On the same day, the left knee was aspirated of 35cc under sterile conditions.The patient tolerated the aspiration well and was aware to place an ice bag over the site tonight.The culture was sent for anaerobic, aerobic, gram stain, cell count and crystal analysis.Results were as follows: synovial fluid culture: no anaerobes recovered, gram stain: few poly morphonuclear cells (pmn's), moderate rbc's, no organisms, no growth at 4 days.Patient was given a prescription for a hinge brace.Patient would return for re-evaluation in 4 days.Patient's husband implied that the synvisc one injection was given directly into the quadriceps muscle, but there was no evidence of fluid or injury within the quadriceps.There was however evidence of fluid within the joint which was where the synvisc was injected.According to physician, this led to a reaction and this increased the production of fluid within her knee.Patient was advised to tell future doctors to never give her synvisc one because of this apparent reaction and was recommended that she should be given a brace prescription for her knee.On (b)(6) 2017, patient was reevaluated for left knee and still had pain in left knee.Patient was noted to have a moderate amount of effusion within the knee.No crepitation was noted beneath the kneecap with flexion and extension.Patient was discouraged from another aspiration and that the effusion appeared to be markedly reduced from the last aspiration.Patient was encouraged to perform rheumatologic testing to make certain there was not a rheumatologic cause for her continued complaints of pain.On (b)(6) 2017, patient presented with knee pain, location was on the left and at the joint line, described as tenderness and chronic.Symptoms were increasing.On an unknown date in (b)(6) 2017, the complaint restricted weight bearing activity (intensity: moderate).As of (b)(6) 2017, patient complained of arthralgia, joint pain, joint swelling, knee pain, and swelling.On the same day, patient's musculoskeletal examination showed that the gait was asymmetric and abnormal stride length.There was swelling in the left knee, tender joint line and pain with flexion and extension in left knee.On an unknown date in (b)(6) 2017, patient's white blood cell count was elevated.On (b)(6) 2017, patient complaint of sharp pain in left knee.There was minimal restricted range of motion.Physician could not feel any significant effusion nor was there erythema in the knee.On the same day, an aspiration was attempted in the left knee under sterile conditions, but were unable to aspirate any fluid to send for culture.The patient tolerated the aspiration well and was aware to place an ice bag over the site tonight.Patient was given a prescription for ciprofloxacin.On (b)(6) 2018, patient was diagnosed with primary osteoarthritis of left knee, plantar fasciitis, bilateral, bilateral carpel tunnel syndrome right and left foot pain and pes planus of both feet.Patient was taking non steroidal anti-inflammatory drugs (nsaid's) for pain.On (b)(6) 2018, patient presented for reevaluation to exclude an inflammatory arthritis.Patient was told that it was some kind of infection and was given antibiotics that cleared her elevated white count and it was now normal.Patient's left knee still hurts, pain in both hands was carpel tunnel syndrome and patient had flat feet and planar fasciitis being treated by podiatry.Patient had no evidence of inflammatory arthritis such as rheumatoid arthritis at this point.Patient was to wear splints in the evening and was also given a new prescription for carpal tunnel splints.Corrective treatment: walker for wasn't able to move my leg, wasn't able to walk for weeks; celecoxib (200 mg 1 capsule), ciprofloxacin (500 mg twice a day), hydrocodone acetaminophen (1 tablet a day) and meloxicam (15 mg; 1 tablet a day), hydrocodone bitartarate, paracetamol (norco), hydromorphone hydrochloride (dilaudid), tramadol and ibuprofen (motrin) for severe pain; not reported for other events.Outcome: not recovered for gait inability, device malfunction, arthralgia; recovering for can't bend knee, can't do any workout and unknown for other events.A product technical complaint (ptc) was initiated on 25-jan-2018 for synvisc one.Batch number: 7rsl021; local ptc number: 54165; global ptc number: (b)(4).Returned: not available, date returned: investigation overview: 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 was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criteria: hospitalization/prolongation for: device malfunction, wasn't able to move my leg, wasn't able to walk for weeks and severe pain.Additional information was received on 26-feb-2018.Global ptc number and ptc results added.Text amended accordingly.Additional information was received on (b)(6) 2018 from the patient.This case initially considered non serious was upgraded to serious as the serious events of device malfunction, wasn't able to move my leg, wasn't able to walk for weeks, severe pain with seriousness criteria as hospitalization/prolongation were added.Also the event of can't bend knee, can't do any workout was added.The suspect product indication, batch/lot number and start date was added.The history of meniscus issue was added.Clinical course updated.Text was amended accordingly.Follow up was received on 04-apr-2018 from non-healthcare professional (attorney).No new information was added.Additional information was received on 19-jul-2018.Concomitant medications, medical history and past drugs were added.Event verbatim of experienced an adverse reaction/suffered injuries was updated and reporter causality for same was updated from unassessable to related.Text was amended accordingly.Additional information was received on 27-jul-2018 from a physician.The case was medically confirmed.Additional events of had restricted weight bearing difficulty, small posterior popliteal cyst, leukocytosis, tingling in left foot, numbness in left foot, left foot appeared swollen, knee edema, no relief from synvisc one injection (device ineffective), plantar fasciitis, bilateral, bilateral carpel tunnel syndrome, right and left foot pain, pes planus of both feet were added along with details.Event experienced an adverse reaction/suffered injuries was deleted.Event term wasn't able to move leg, wasn't able to walk for weeks was updated to wasn't able to move leg, wasn't able to walk for weeks/walking difficulty, severe pain was updated to severe pain/knee pain/joint pain/stabbing, burning and throbbing pain.Symptom pain with flexion and extension in left knee, swelling/joint swelling was added.Event took lots of fluid out of knee was updated as symptom of arthralgia.Additional suspect product solu-medrol was added along with details.Outcome of can't bend knee, can't do any workout was updated from not recovered to recovering.Clinical course was updated and text was amended accordingly.Additional information was received on 12-oct-2018.Investigation summary received as the case was updated to serious in previous version.Text amended accordingly.
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