| Lot Number 7RSL021 |
| Device Problems
Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Weakness (2145); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); Loss of consciousness (2418); No Code Available (3191)
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| Event Date 01/01/2017 |
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Event Type
Injury
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Event Description
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This unsolicited case from united states was received on 22-dec-2017 from a patient.This case concerns a (b)(6) female patient who received treatment with synvisc one and on the same day had had swelling above her knees, excruciating pain/ hurt so much that she cried from the pain, knees swelled to twice their normal size; after one day passed out; after an unknown latency could not bear weight at all, threw up, wake up at night with hot flashes, anxiety.The patient has had two previous synvisc one injections without any problems.The last synvisc one injection was approximately six months before this one, around (b)(6) 2017.No relevant concomitant medications, medical history, and concurrent condition were reported.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection, once (indication, dose, batch/lot number and expiry date: not reported) in both knees.There was nothing unusual about the procedure and afterward she went home to rest the knees.She was just sitting, watching the news when she started having terrible symptoms all of the sudden, like gangbusters.On the same day, patient experienced excruciating pain, 10 on a scale of 1-10 and her knees swelled to twice their normal size.The patient had swelling above her knees, too.It hurt so much that she cried from the pain.On (b)(6) 2017, one day after receiving injection, patient stated that the next afternoon, she passed out, perhaps from the pain and when she woke up, she threw up (onset date: (b)(6) 2017; latency unknown).Patient had no pain before the injections and no trouble bearing weight on the knees.On an unknown date in 2017, latency unknown, after the injections, patient could not bear weight at all, used a walker for two or three days, then a cane after that to help her get around.The patient did not have a fever that she was aware of, but did wake up at night with hot flashes for no apparent reason about a week after the injections (onset date: (b)(6) 2017; latency unknown).Patient wondered whether it was from anxiety.The hot flashes resolved.The patient's pain started to get better after three days, but the swelling stayed longer, especially above her knees.Patient stated that the swelling was resolved and her pain was not too bad now.Patient was getting better and better.There was no fluid drained from the knees and no bloodwork or cultures were done.The patient used ice and ibuprofen for the pain and swelling.Ice helped the most.The patient stated that she has no prosthetic devices and suffered from no chronic diseases like diabetes or high blood pressure.Patient was active and worked out.Patient went to her doctor to have fluid drawn from the knees to be cultured, but her doctor told her that the bacteria was slow growing and might not show up right away, so no fluid was removed.Patient had an appointment to go back next month.Corrective treatment: used a walker and cane for could not bear weight at all; ice and ibuprofen for had swelling above her knees, excruciating pain/hurt so much that she cried from the pain, knees swelled to twice their normal size.Outcome: recovered for passed out, had swelling above her knees, wake up at night with hot flashes, knees swelled to twice their normal size; recovering for rest events a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criterion: permanent or significant disability for could not bear weight at all; important medical event for passed out.Pharmacovigilance comment: sanofi company comment dated 29-dec-2017: this case concerns a female patient who has received treatment with synvisc one and later could not bear weight at all and passed out.The event of could not bear weight was assessed as possible due to the temporal relationship and pharmacological plausability whereas passed out has been assessed as unlikely as it has been reported that the event occured due to the pain.
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Event Description
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This unsolicited case from united states was received on 22-dec-2017 from a patient.This case concerns a (b)(6) female patient who received treatment with synvisc one and on the same day had swelling above her knees, excruciating pain/ hurt so much that she cried from the pain, knees swelled to twice their normal size; after one day passed out; after an unknown latency could not bear weight at all, threw up, wake up at night with hot flashes, anxiety the patient has had two previous synvisc one injections without any problems.The last synvisc one injection was approximately six months before this one, around (b)(6) 2017.No relevant concomitant medications, medical history, and concurrent condition were reported.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection, once (indication, dose, batch/lot number and expiry date: not reported) in both knees.There was nothing unusual about the procedure and afterward she went home to rest the knees.She was just sitting, watching the news when she started having terrible symptoms all of the sudden, like gangbusters.On the same day, patient experienced excruciating pain, 10 on a scale of 1-10 and her knees swelled to twice their normal size.The patient had swelling above her knees, too.It hurt so much that she cried from the pain.On (b)(6) 2017, one day after receiving injection, patient stated that the next afternoon, she passed out, perhaps from the pain and when she woke up, she threw up (onset date: (b)(6) 2017; latency unknown).Patient had no pain before the injections and no trouble bearing weight on the knees.On an unknown date in 2017, latency unknown, after the injections, patient could not bear weight at all, used a walker for two or three days, then a cane after that to help her get around.The patient did not have a fever that she was aware of, but did wake up at night with hot flashes for no apparent reason about a week after the injections (onset date: (b)(6) 2017; latency unknown).Patient wondered whether it was from anxiety.The hot flashes resolved.The patient's pain started to get better after three days, but the swelling stayed longer, especially above her knees.Patient stated that the swelling was resolved and her pain was not too bad now.Patient was getting better and better.There was no fluid drained from the knees and no bloodwork or cultures were done.The patient used ice and ibuprofen for the pain and swelling.Ice helped the most.The patient stated that she has no prosthetic devices and suffered from no chronic diseases like diabetes or high blood pressure.Patient was active and worked out.Patient went to her doctor to have fluid drawn from the knees to be cultured, but her doctor told her that the bacteria was slow growing and might not show up right away, so no fluid was removed.Patient had an appointment to go back next month.Corrective treatment: used a walker and cane for could not bear weight at all; ice and ibuprofen for had swelling above her knees, excruciating pain/hurt so much that she cried from the pain, knees swelled to twice their normal size outcome: recovered for passed out, had swelling above her knees, wake up at night with hot flashes, knees swelled to twice their normal size; recovering for rest events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 51585 the product lot number was not provided; therefore a batch record review was 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 was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers and assessed 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.Seriousness criterion: permanent or significant disability for could not bear weight at all; important medical event for passed out additional information was received on 02-jan-2018.Global ptc number and ptc results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 2-jan-2018: this case concerns a female patient who has received treatment with synvisc one and later could not bear weight at all and passed out.The event of could not bear weight was assessed as possible due to the temporal relationship and pharmacological plausibility whereas passed out has been assessed as unlikely as it has been reported that the event occured due to the pain.
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Event Description
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This unsolicited case from united states was received on 22-dec-2017 from a patient.This case concerns a (b)(6) year old female patient who received treatment with synvisc one and on the same day had had swelling above her knees, excruciating pain/ hurt so much that she cried from the pain/ extreme pain, knees swelled to twice their normal size, passed out/ fainted; after an unknown latency could not bear weight at all, threw up/vomiting, wake up at night with hot flashes, anxiety.Also, device malfunction was identified for the reported lot number.The patient has had two previous synvisc one injections without any problems.The last synvisc one injection was approximately six months before this one, around (b)(6) 2017.Medical history included knee pain.Concomitant medications reported include atorvastatin calcium for high cholesterol, celecoxib, centrum, colecalciferol (vitamin d3), calcium for bone health and trazodone for sleep.The patient had no allergies.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/lot number: 7rsl021 and expiry date: 31- may-2020) for knee pain in both knees.There was nothing unusual about the procedure and afterward she went home to rest the knees.She was just sitting, watching the news when she started having terrible symptoms all of the sudden, like gangbusters.On the same day, patient experienced excruciating pain, 10 on a scale of 1-10 and her knees swelled to twice their normal size.The patient had swelling above her knees, too.It hurt so much that she cried from the pain.At 5:00 pm, the patient started to experience extreme pain and called summit ortho but a recording stated to call 911.The patient took â½ tablet of hydrocodone 5-325 and iced knee all night.The pain was excruciating and the patient fainted.When the patient woke up, the patient vomited.The patient applied more ice and another â½ tablet of hydrocodone.The patient felt better but needed to ice and acetylsalicylic acid (aspirin).On (b)(6) 2017, one day after receiving injection, patient stated that the next afternoon, she passed out, perhaps from the pain and when she woke up, she threw up.Patient had no pain before the injections and no trouble bearing weight on the knees.On an unknown date in 2017, latency unknown, after the injections, patient could not bear weight at all, used a walker for two or three days, then a cane after that to help her get around.The patient did not have a fever that she was aware of, but did wake up at night with hot flashes for no apparent reason about a week after the injections (onset date: (b)(6) 2017; latency unknown).Patient wondered whether it was from anxiety.The hot flashes resolved.The patient's pain started to get better after three days, but the swelling stayed longer, especially above her knees.Patient stated that the swelling was resolved and her pain was not too bad now.Patient was getting better and better.There was no fluid drained from the knees and no bloodwork or cultures were done.The patient used ice and ibuprofen for the pain and swelling.Ice helped the most.The patient stated that she has no prosthetic devices and suffered from no chronic diseases like diabetes or high blood pressure.Patient was active and worked out.Patient went to her doctor to have fluid drawn from the knees to be cultured, but her doctor told her that the bacteria was slow growing and might not show up right away, so no fluid was removed.Patient had an appointment to go back next month.It was reported that the patient wanted a total knee replacement.Reportedly, the patient wanted reimbursement for medical expenses.On (b)(6) 2017, complete blood count, erythrocyte sedimentation rate and c-reactive protein were normal.Corrective treatment: used a walker and cane for could not bear weight at all; ice and ibuprofen for had swelling above her knees, knees swelled to twice their normal size; ice, ibuprofen, acetylsalicylic acid (aspirin), hydrocodone and codeine/paracetamol (acetaminophen w/codeine) for excruciating pain/hurt so much that she cried from the pain/ extreme pain; not reported for rest all events outcome: recovered for had swelling above her knees, wake up at night with hot flashes, knees swelled to twice their normal size; recovering for rest events a pharmaceutical technical complaint (ptc) was initiated with 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.Seriousness criterion: permanent or significant disability for device malfunction, could not bear weight at all; important medical event for passed out/ fainted additional information was received on 02-jan-2018.Global ptc number and ptc results were added.Text was amended accordingly.Additional information was received on 16-jan-2018 from the patient.The information regarding the total knee replacement and reimbursement for medical expenses wanted by the patient was added.Text was amended accordingly.Additional information was received on 30-jan-2018 from patient.Medical history, concomitant medications and concurrent condition was added.Suspect details (dose, indication and lot details) were added.Additional event of device malfunction was added.The event of excruciating pain/hurt so much that she cried from the pain was updated to excruciating pain/hurt so much that she cried from the pain/ extreme pain and corrective treatment was added.The event of passed out was updated to passed out/ fainted, start date and outcome was updated.The event of threw up was updated to threw up/vomiting and start date was updated.Clinical course was updated.Text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 30-jan-2018: this case concerns a female patient who has received treatment with synvisc one injection from the recalled lot and later could not bear weight at all and passed out.The event of could not bear weight was assessed as possible due to the temporal relationship and pharmacological plausability whereas passed out has been assessed as unlikely as it has been reported that the event occured due to the pain.Furthermore, the concerned lot number has been identified to have malfunction by the company.
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Event Description
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Could not bear weight at all [weight bearing difficulty] device malfunction [device malfunction].Passed out/ fainted [passed out].Excruciating pain/hurt so much that she cried from the pain/ extreme pain/sharp, dull and aching [knee pain].Had swelling above her knees [swelling of legs].Hemoglobin low [hemoglobin low].Threw up/vomiting [vomiting].Wake up at night with hot flashes [hot flashes].Anxiety [anxiety].Range of motion on right and left with pain/ could not walk without pain [pain upon movement].Painful patellar crepitus [joint crepitation].Weakness [weakness].Flexed knee gait [abnormal gait].1+ effusion [effusion (l) knee].1+ effusion [effusion (r) knee].Stiffness [joint stiffness].Knees swelled to twice their normal size [swelling of knees].Case narrative: this case is cross-referenced with case id: (b)(4).(same patient).Initial information received on 22-dec-2017 from united states regarding an unsolicited valid legal serious malfunction case received from a patient.This case concerns a 73 year old female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and on the same day had had swelling above her knees, knees swelled to twice their normal size, threw up/vomiting, passed out/ fainted, excruciating pain/hurt so much that she cried from the pain/ extreme pain/sharp, dull and aching (latency: (same day) after 3 hrs 45 min); after an unknown latency could not bear weight at all, anxiety, wake up at night with hot flashes (latency: few days); stiffness, weakness, painful patellar crepitus, 1+ effusion, range of motion on right and left with pain/ could not walk without pain (latency:10 days), flexed knee gait (latency: 2 months 8 days 10 hrs 45 min), hemoglobin low (latency: 3 months 5 days).Also, device malfunction was identified for the reported lot number.The patients past medical history included knee pain, tonsillectomy, fracture, arthroscopy knee in 2004, pneumococcal pneumonia.The patients concurrent conditions included acquired varus deformity knee, osteoporosis, allergy to hydrocodone-acetaminophen (norco), arthritis, pain in hand, muscle weakness, primary osteoarthritis of first metacarpal joint of one hand, primary localized osteoarthritis of both knees, stiffness of finger joint, strain of biceps muscle, right, never a smoker, alcohol drinker.The past vaccination included pneumococcal vaccine.The patient had no known environmental allergies.Family history included colon cancer (nephew).The past medical treatment (s) was not reported.Concomitant medications reported include atorvastatin calcium for high cholesterol, celecoxib, centrum, colecalciferol (vitamin d3), calcium for bone health and trazodone for sleep, celecoxib (celebrax), duloxetine hydrochloride (cymbalta), medroxyprogesterone acetate ( depo-provera), fish oil, atorvastatin calcium (lipitor), lorazepam, magnesium, multivitamin (vitamin nos), omeprazole, oxycodone hcl, prochlorperazine maleate, eletriptan hydrobromide (relpax), tizanidine hcl, vitamin d nos (vitamin d).The patient had no allergies.On (b)(6) 2017 at 13:15 hours, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/lot number: 7rsl021 and expiry date: 31-may-2020) for primary localized osteoarthritis of both knees and knee pain in both knees.The device malfunction was identified for the reported lot number (medically significant).A right and left intra-articular knee injection with 2cc of marcaine and 6ml of hylan g-f 20, sodium hyaluronate was given and the patient tolerated the procedure well.There was nothing unusual about the procedure and afterward she went home to rest the knees.She was just sitting, watching the news when she started having terrible symptoms all of the sudden, like gangbusters.On the same day, patient experienced excruciating pain (intervention required), 10 on a scale of 1-10 and her knees swelled to twice their normal size.The patient had swelling above her knees, too.It hurt so much that she cried from the pain.At 5:00 pm, the patient started to experience extreme pain and called summit ortho but a recording stated to call 911.The patient took a tablet of hydrocodone 5-325 and iced knee all night.The pain was excruciating and the patient fainted.When the patient woke up, the patient vomited.The patient applied more ice and another tablet of hydrocodone.The patient felt better but needed to ice and acetylsalicylic acid (aspirin).On 18-nov-2017, one day after receiving injection, patient stated that the next afternoon, she passed out (medically significant), perhaps from the pain and when she woke up, she threw up.Patient had no pain before the injections and no trouble bearing weight on the knees (disability).On (b)(6) 2017, patient reported for follow up to discuss possible total knee arthroplasty.She had continued pain in her knees which limited her daily activities, affected her sleep at night and made it difficult for her to go up and down the stairs.The patient rated her pain at 0 on a scale of 10, currently and rated it 6 on a scale of 10 at its worst.Her pain was aching and associated with stiffness (latency: 10 days) and weakness.Further, her pain was aggravated upon standing, climbing and getting out of chair and relieved by stretching, prescriptions medicines, massage and ice.The same day, upon examination, patient had painful patellar crepitus (latency:10 days) and her knee was tender on palpation along medial joint line, further 1+ effusion (latency: 10 days) and range of motion on right and left with pain (latency: 10 days).The skin was warm and dry.On 28-nov-2017, patient underwent ct scan of right lower extremity which revealed medial predominant, tricompartmental right knee osteoarthritis and moderate to large sized joint effusion with suprapatellar loose bodies.On an unknown date in 2017, latency unknown, after the injections, patient could not bear weight at all, used a walker for two or three days, then a cane after that to help her get around.The patient did not have a fever that she was aware of but did wake up at night with hot flashes for no apparent reason about a week after the injections (onset date: (b)(6) 2017; latency few days).Patient wondered whether it was from anxiety.The hot flashes resolved.The patient's pain started to get better after three days, but the swelling stayed longer, especially above her knees.Patient stated that the swelling was resolved and her pain was not too bad now.Patient was getting better and better.There was no fluid drained from the knees and no bloodwork or cultures were done.The patient used ice and ibuprofen for the pain and swelling.Ice helped the most.The patient stated that she has no prosthetic devices and suffered from no chronic diseases like diabetes or high blood pressure.Patient was active and worked out.Patient went to her doctor to have fluid drawn from the knees to be cultured, but her doctor told her that the bacteria was slow growing and might not show up right away, so no fluid was removed.Patient had an appointment to go back next month.It was reported that the patient wanted a total knee replacement.Reportedly, the patient wanted reimbursement for medical expenses.On(b)(6) 2017, complete blood count, erythrocyte sedimentation rate and c-reactive protein were normal.On (b)(6) 2017, patient reported for follow of her inflammatory response from the injection and reported she had significant swelling and pain after the injection and had improved significantly as of now and her pain and swelling had subsided.The patient was advised to follow up in four weeks.On (b)(6) 2018, patient reported for follow up of her knee pain and upon examination it was noted that she did not have any tenderness over the medial or lateral, patient has flexed knee gait (latency: 2 months 9 days).The patients wished to proceed with bilateral total knee arthroscopy.The patient could not walk without pain.Patient rated her pain 8 on a scale of 10 and it was sharp, dull and aching in nature.On (b)(6) 2018, patient under ct scan of left knee and revealed advanced tricompartmental left knee osteoarthritis.On (b)(6) 2018, patient underwent bilateral total knee arthroplasty for her right knee pain.The patient was given spinal anesthesia.The right side was started first and bilateral high thigh pneumatic tourniquet was applied and legs were drapped in sterile manner.The incision was made.The bony surfaces were prepared with pulse lavage of cement was poured in the tibial cavity very liquid state and then on the back of the tibial component the tibia was impacted excess cement was removed in like fashion femoral component was impacted.The initial computer plan i called for 6 mm insert radius 7 worked much better give her full extension better stability.The joint was thoroughly irrigated with betadine lap sponge placed in the wound and then the knee was wrapped with coban and the tourniquet was let down.Then, the joint was irrigated, achieved hemostasis suspecting posterior compartment medial lateral gutters had reasonable control bleeding.And snapped in the actual insert on the right knee the insert in the right knee was a size 57 million attune insert.The femoral component was also size 5 erueiate retaining standard width.After the hemostasis was achieved, joint was irrigated with the trial in the 70 able to good stability.We snapped in the actual 7 mm insert injected the posterior capsule with more the joint juice as well as the medial lateral gutters.Used 30 ee of the joint juice on the right knee.Medial parapatellar incision was closed mid patella proximal with a running suture of #1 vicryl in interrupted sutures distally.On 22-feb-2018, laboratory test revealed hemoglobin low (latency: 3 months 5 days) as 8.2 g/dl (reference range: 12-16).On (b)(6) 2018, patient reported for follow up after her bilateral total knee arthroplasty.She showed stable early progression with the knee and the incisions were healing well.The patient was advised to continue with ted stockings and 325mg aspirin twice daily with meals until the 30 day mark.Patient would continue periodic icing and knee elevation as needed for swelling.Patient was advised to follow up in 1 month to reassess progress.On (b)(6) 2018, patient reported to the clinic for follow of her bilateral arthroplasty and her progression was good.The patient was advised to continue with physical therapy and home program for ongoing range of motion and strengthening.Patient was advised to follow up after 6 months to reassess the progress.Final diagnosis was could not bear weight at all, anxiety, wake up at night with hot flashes, knees swelled to twice their normal size, threw up/vomiting, had swelling above her knees, passed out/ fainted, device malfunction, excruciating pain/hurt so much that she cried from the pain/ extreme pain/sharp, dull and aching, stiffness, 1+ effusion, 1+ effusion, weakness, painful patellar crepitus, range of motion on right and left with pain/ could not walk without pain, flexed knee gait and hemoglobin low.Action taken: not applicable.Corrective treatment: used a walker and cane for could not bear weight at all; ice and ibuprofen for had swelling above her knees, knees swelled to twice their normal size; ice, ibuprofen, acetylsalicylic acid (aspirin), hydrocodone and codeine/paracetamol (acetaminophen w/codeine), stretching, massage and bilateral total knee arthroplasty for excruciating pain/hurt so much that she cried from the pain/ extreme pain/sharp, dull and aching; not reported for rest all events outcome: recovering / resolving for could not bear weight at all, device malfunction, passed out/ fainted, threw up/vomiting, anxiety, excruciating pain/hurt so much that she cried from the pain/ extreme pain/sharp, dull and aching; recovered / resolved had swelling above her knees, wake up at night with hot flashes, knees swelled to twice their normal size, unknow for weakness, stiffness painful patellar crepitus, 1+ effusion, flexed knee gait, hemoglobin low; not recovered / not resolved for range of motion on right and left with pain/ could not walk without pain a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 51585 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 02-jan-2018.Global ptc number and ptc results were added.Text was amended accordingly.Additional information was received on 16-jan-2018 from the patient.The information regarding the total knee replacement and reimbursement for medical expenses wanted by the patient was added.Text was amended accordingly.Additional information was received on 30-jan-2018 from patient.Medical history, concomitant medications and concurrent condition was added.Suspect details (dose, indication and lot details) were added.Additional event of device malfunction was added.The event of excruciating pain/hurt so much that she cried from the pain was updated to excruciating pain/hurt so much that she cried from the pain/ extreme pain and corrective treatment was added.The event of passed out was updated to passed out/ fainted, start date and outcome was updated.The event of threw up was updated to threw up/vomiting and start date was updated.Clinical course was updated.Text amended accordingly.Additional information received on 08-aug-2019 from lawyer.Case classification updated to legal.Medical history of tonsillectomy, arthroscopy knee, pneumococcal pneumonia, acquired varus deformity knee, osteoporosis, arthritis, pain in hand, allergy to hydrocodone-acetaminophen, muscle weakness, primary osteoarthritis of first metacarpal joint of one hand, primary localized osteoarthritis of both knees, stiffness of finger joint, strain of biceps muscle, right, never a smoker, alcohol drinker.Vaccination of pneumococcal vaccine.Suspect product indication of primary localized osteoarthritis of both knees added.Corrective treatment added for excruciating pain/hurt so much that she cried from the pain/ extreme pain.Events of stiffness, weakness, painful patellar crepitus, 1+ effusion, range of motion on right and left with pain/ could not walk without pain, flexed knee gait, hemoglobin low.Verbatim updated from excruciating pain/hurt so much that she cried from the pain/ extreme pain to excruciating pain/hurt so much that she cried from the pain/ extreme pain/sharp, dull and aching and event updated to serious.Concomitant medication added.Clinical course updated.Text amended accordingly.
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Search Alerts/Recalls
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