| Lot Number 7RSL021 |
| Device Problem
Microbial Contamination of Device (2303)
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| Patient Problems
Anemia (1706); Glaucoma (1875); Pain (1994); Thyroid Problems (2102); Weakness (2145); Chills (2191); Arthralgia (2355); Joint Swelling (2356); Respiratory Tract Infection (2420); No Code Available (3191)
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| Event Date 04/30/2018 |
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Event Type
malfunction
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Event Description
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Device malfunction [device malfunction].Open angle glaucoma, suspected low risk bilateral/borderline glaucoma with ocular hypertension, bilateral [open angle glaucoma].Cellulitis of left leg/left tibial cellulitis [cellulitis of leg] ([foot pain], [redness], [extremities burning sensation of], [lower extremity mass]).Chest tightness [chest tightness].Polydipsia [polydipsia].Elevated tsh [tsh increased].Pain localized to the general lower extremity [pain of lower extremities].Elevated t4 [t4 increased].Iron deficiency anemia [iron deficiency anemia].Plantar fasciitis, left [plantar fasciitis].Viral uri with cough, unspecified [viral upper respiratory tract infection] ([productive cough], [sore throat], [mucus discharge], [sinus pain]).Watery eyes [watering eyes].Body aches [general body pain].Poor appetite [decreased appetite].Osteoarthritis left mid foot [foot osteoarthritis].Aggravated constantly, with normal activities, in bed, bending, using stairs, rising from a chair at higher levels of activity [pain upon movement].Weakness [weakness].Chills [chills].Trouble walking distances/limping [walking difficulty].Some pain/localized to medial, lateral, anterior and posterior knee/joint painful, described pain as aching, cramping, radiating, sharp [knee pain] ([condition aggravated], [subtherapeutic response]).Some swelling [swelling of l knee] ([condition aggravated]).Effusion left knee 1+ [effusion (l) knee].Case narrative: this case was cross referenced with case (b)(6) (same patient).Initial information received from united states on 19-feb-2019 regarding an unsolicited valid serious legal case received from a lawyer.This case involves a (b)(6) years old female patient who had open angle glaucoma, suspected low risk bilateral/borderline glaucoma with ocular hypertension, bilateral (latency: 7 months 3 days), cellulitis of left leg/left tibial cellulitis (latency: 6 months 7 days), elevated tsh, elevated t4 (latency: 6 months 22 days), iron deficiency anemia (latency: 5 months 10 days), osteoarthritis left mid foot (latency: 5 months 21 days), plantar fasciitis, left (latency: 6 months 23 days), viral uri with cough, unspecified (latency: 7 months 10 days) chest tightness, polydipsia, pain localized to the general lower extremity, watery eyes, poor appetite, body aches, weakness, chills, trouble walking distances/limping, some swelling, effusion left knee 1+, aggravated constantly, with normal activities, in bed, bending, using stairs, rising from a chair at higher levels of activity (latency: unknown), some pain/localized to medial, lateral, anterior and posterior knee/joint painful, described pain as aching, cramping, radiating and sharp (latency: 0 day), after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).A device malfunction was noted in the reported batch number.Medical history included extraction teeth on 1980, knee injury in 1985, cholecystectomy in 1986, smoker until (b)(6) 2011 (duration: 5 years), influenza immunization (tiv (im) on (b)(6) 2012 and (b)(6) 2013, iiv3, im pres free on (b)(6) 2014 and on (b)(6) 2014, iiv4, im pres free on (b)(6) 2016), upper gastrointestinal endoscopy on (b)(6) 2013, hepatitis a immunization on (b)(6) 2016, achilles tendon repair in 2013 and (b)(6) 2014, cesarean section twice, excision partial talus/calcaneus, intraoperative fluoroscopy on (b)(6) 2014, limited strength, limited range of motion, impaired gait, chronic bilateral knee pain, limited muscular endurance since (b)(6) 2017, hysteroscopy, endometrium (curettage) on (b)(6) 2017, adenoid surgery, synvisc for osteoarthritis knee (administered 8-9 months before (b)(6) 2017: reduced the pain), knee arthroscopy, abdominal pain, arthritis, dyspareunia, fatigue, tubal ligation, visual disturbance, nausea, frequency, numbness, hematuria, tiredness with difficulty falling back to sleep, periodic limb movement disorder, acute cystitis without hematuria.Family history included alcohol abuse (son), alzheimer's disease, arthritis (father, mother), brain cancer (maternal grandmother), colon cancer (paternal grandmother), depression (brother, mother, son), diabetes, glaucoma (mother), heart disease (mother), high blood pressure: hypertension (mother, father), hyperlipidemia: elevated cholesterol (mother), leukemia (paternal grandfather), myocardial infarction: heart attack (mother), osteoarthritis (father), osteoporosis: thinning of bones (father).Patient had ongoing chronic essential hypertension, chronic depression, chronic polycystic ovarian syndrome (irregular menses, hirsutism, hyperglycemia, possible endometriosis hx, dysmenorrhea, provera use leads to vulvar furuncles), chronic mixed headache syndrome, irritable bowel syndrome since (b)(6) 2012, stress incontinence, chronic furuncles since (b)(6) 2012, chronic cough since (b)(6) 2012, calcaneal spur since (b)(6) 2013, chronic hiccoughs since (b)(6) 2013, generalized anxiety disorder, unspecified anxiety since (b)(6) 2013, equinus deformity of foot, acquired since (b)(6) 2013, haglund's deformity since (b)(6) 2013, dysphagia since (b)(6) 2013, morbid obesity since (b)(6) 2013, tachycardia since (b)(6) 2014, chronic fatty liver disease, nonalcoholic since (b)(6) 2014, restless legs syndrome since (b)(6) 2014, chronic back pain since (b)(6) 2014, blurry vision (endorses worsening blurry distance vision), chronic allergic rhinitis due to pollen, chronic muscle spasms of lower extremity since (b)(6) 2015, primary osteoarthritis of both knees since (b)(6) 2016, snoring since (b)(6) 2017, achilles tendinitis (right leg contracture, intermittent ankle edema), since (b)(6) 2017, plantar fascitis, right since (b)(6) 2017, hypersomnia since (b)(6) 2017, gastroesophageal reflux disease, depression, unspecified, occupational disabled, hepatic steatosis, blood sugar increased/hyperglycemia (once around 200), ace inhibitors and zofran allergy (cough due to ace inhibitors, itching with zofran), uncontrolled diabetes mellitus type ii without complication, abscesses in pannus of abdomen, hidradenitis suppurativa vs recurrent (b)(6) furunculosis, idiopathic peripheral neuropathy (worse in feet, extends to knees worsening over past one and half year), bilateral carpal tunnel syndrome and had surgery for the same, recurrent sneezing, congestion and rhinorrhea, hepatomegaly, diarrhea and constipation due to alternating bowel habits, recurrent numbness and light headedness, mild sensory polyneuropathy.Concomitant medications included paracetamol (tylenol extra-strength); dicycloverin hydrochloride (bentyl); plantago ovata (metamucil); sulfamethoxazole, trimethoprim (bactrim ds); amlodipine besilate (norvasc); bupropion hydrochloride (wellbutrin); buspirone hydrochloride (buspar) for anxiety; celecoxib (celebrex); cetirizine hydrochloride (zyrtec); chlorhexidine gluconate (hibiclens); chlorthalidone; clindamycin phosphate (cleocin t); clonazepam (klonopin) for anxiety; diclofenac sodium (voltaren); esomeprazole sodium (nexium); mometasone furoate (flonase); gabapentin (neurontin); hydrocortisone; losartan potassium (cozaar); metformin hydrochloride (glucophage); potassium chloride (klor-con); pramipexole dihydrochloride (mirapex); and vortioxetine.On (b)(6) 2017, the patient started using hylan g-f 20, sodium hyaluronate, intra-articular injection at the dose of 6 ml, once (lot - 7rsl021) for osteoarthritis of left knee.It was reported that complete relief for 1 hour but then worsening pain (latency: 0 day).Patient had some pain and within first week of injection had swelling which improved slightly but had since worsened.Patient stated that the pain was similar now to what it was before the injection (latency: unknown).When joint was painful, patient described as aching, cramping, radiating and sharp marked (major pain with significant limitations) pain.Symptoms have been present for 1 month and has moderately worsened since their previous visit.Pain was aggravated constantly, with normal activities, in bed, bending, using stairs, rising from a chair, at higher levels of activity and without relationship to any activity.Pain is localized to the general lower extremity, medial knee, lateral knee, anterior knee and posterior knee.The patient had tried ice and rest to help with the pain.She has tried celecoxib, ibuprofen, meloxicam (mobic), naproxen, diclofenac sodium and cefixime (flexeril) with no change.Pain was relieved by nothing adequately tried by patient.Patient stated that she received her letter stating a recall of her hylan g-f 20, sodium hyaluronate injection, but she has not had any symptoms described other than continued pain.Patient denies any fevers, nausea, vomiting, or erythematous joint and stated that her swelling had improved.Patient had moderate limping, effusion of 1+ on (b)(6) 2017.Patient had trouble walking distances because of the knees and complained of polydipsia (latency: unknown).On (b)(6) 2018, patient was diagnosed with iron deficiency anemia (latency: 5 months 10 days).On (b)(6) 2018, patient was diagnosed with left midfoot osteoarthritis, left leg mass (latency: 5 months 21 days).On (b)(6) 2018, patient was diagnosed with cellulitis of left leg.Patient was taking levofloxacin (levaquin) for cellulitis (latency: 6 months 7 days).On (b)(6) 2018, patient had elevated tsh and t4 (latency: 6 months 22 days).On (b)(6) 2018, patient was diagnosed with left plantar fasciitis (latency: 6 months 23 days).On (b)(6) 2018, patient reported that the burning was lessened but she now has plantar pain along the long arch and ball of the foot mostly in both feet; left more painful that right.She has increased pain with increased activity.She must use a scooter at the store as she cannot tolerate walking the distance needed to run her errands.On (b)(6) 2018, patient presented with suspected bilateral open angle glaucoma, low risk, diagnosed with borderline glaucoma with ocular hypertension, bilateral (latency: 7 months 3 days).On (b)(6) 2018, patient was diagnosed with viral upper respiratory tract infection with fatigue, cough, sneezing, body aches, weakness, subjective child, poor appetite, sinus congestion, pain, yellow mucus productive cough with watery eyes and running nose (latency: 7 months 10 days).Patient was advised to have intra-articular glucocorticoid injection but could not do that due to redness and swelling in anterior tibial region which was consistent with cellulitis.By (b)(6) 2018, there was no erythema, warmth or any suggestion of skin infection.Patient attributed the mass on the left leg to the hylan g-f 20, sodium hyaluronate injection.The mass had not had any fluctuance, erythema, tenderness or discharge during the many months the mass has been present.Corrective treatment: levofloxacin for cellulitis of left leg/left tibial cellulitis, ibuprofen, codeine phosphate, guaifenesin, otc nasal saline wash for viral uri with cough, unspecified, metformin for trouble walking distances/limping, ice, naproxen, meloxicam, cefixime, ibuprofen and rest for some pain/localized to medial, lateral, anterior and posterior knee/joint painful, described pain as aching, cramping, radiating, sharp; aggravated constantly, with normal activities, in bed, bending, using stairs, rising from a chair at higher levels of activity; not reported for rest outcome: not recovered for cellulitis of left leg/left tibial cellulitis, iron deficiency anemia, plantar fasciitis, left, viral uri with cough, unspecified, osteoarthritis left mid foot, some pain/localized to medial, lateral, anterior and posterior knee/joint painful, described pain as aching, cramping, radiating, sharp, device malfunction, aggravated constantly, with normal activities, in bed, bending, using stairs, rising from a chair at higher levels of activity; recovering for some swelling, recovered for effusion left knee 1+, unknown for rest a product technical complaint was initiated for synvisc one with batch number 7rsl021: 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 is completed, corrective and preventive actions would be implemented.Seriousness criteria: medically significant for device malfunction, open angle glaucoma, suspected low risk bilateral/borderline glaucoma with ocular hypertension, bilateral, cellulitis of left leg/left tibial cellulitis.
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Event Description
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Device malfunction [device malfunction] open angle glaucoma, suspected low risk bilateral/borderline glaucoma with ocular hypertension, bilateral [open angle glaucoma] cellulitis of left leg/left tibial cellulitis [cellulitis of leg] ([foot pain], [redness], [extremities burning sensation of], [lower extremity mass]) compartment syndrome [compartment syndrome] ([muscle tightness], [redness]) chest tightness [chest tightness] polydipsia [polydipsia] pain localized to the general lower extremity to pain localized to the general lower extremity/legs are real sore/bilateral leg pain [pain of lower extremities] elevated tsh [tsh increased] elevated t4 [t4 increased].Iron deficiency anemia [iron deficiency anemia].Plantar fasciitis, left [plantar fasciitis].Viral uri with cough, unspecified [viral upper respiratory tract infection] ([productive cough], [sore throat], [mucus discharge], [sinus pain]).Watery eyes [watering eyes] body aches [general body pain] poor appetite [decreased appetite] osteoarthritis left mid foot [foot osteoarthritis] aggravated constantly, with normal activities, in bed, bending, using stairs, rising from a chair at higher levels of activity [pain upon movement] weakness [weakness] chills [chills] trouble walking distances/limping/impaired gait [walking difficulty] some pain/localized to medial, lateral, anterior and posterior knee/joint painful, described pain as aching, cramping, radiating, sharp [knee pain] ([condition aggravated], [subtherapeutic response]) some swelling [swelling of l knee] ([condition aggravated]) effusion left knee 1+ [effusion (l) knee].Case narrative: this case was cross referenced with (b)(4).Initial information received from united states on 19-feb-2019 regarding an unsolicited valid serious legal case received from a lawyer.This case involves a 50 years old female patient who had open angle glaucoma, suspected low risk bilateral/borderline glaucoma with ocular hypertension, bilateral (latency: 7 months 3 days), cellulitis of left leg/left tibial cellulitis (latency: 6 months 7 days), elevated tsh, elevated t4 (latency: 6 months 22 days), iron deficiency anemia (latency: 5 months 10 days), osteoarthritis left mid foot (latency: 5 months 21 days), plantar fasciitis, left (latency: 6 months 23 days), viral uri with cough, unspecified (latency: 7 months 10 days) chest tightness, polydipsia, pain localized to the general lower extremity, watery eyes, poor appetite, body aches, weakness, chills, trouble walking distances/limping/impaired gait, some swelling, effusion left knee 1+, aggravated constantly, with normal activities, in bed, bending, using stairs, rising from a chair at higher levels of activity (latency: unknown), some pain/localized to medial, lateral, anterior and posterior knee/joint painful, described pain as aching, cramping, radiating and sharp (latency: 0 day), pain localized to the general lower extremity to pain localized to the general lower extremity/legs are real sore/bilateral leg pain, compartment syndrome (latency: unknown) after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).A device malfunction was noted in the reported batch number.Medical history included extraction teeth on 1980, knee injury in 1985, cholecystectomy in 1986, smoker until 11-sep-2011 (duration: 5 years), influenza immunization (tiv (im) on 04-oct-2012 and 16-dec-2013, iiv3, im pres free on 09-oct-2014 and on 03-dec-2014, iiv4, im pres free on 06-dec-2016), upper gastrointestinal endoscopy on 07-may-2013, hepatitis a immunization on 06-dec-2016, achilles tendon repair in 2013 and 11-mar-2014, cesarean section twice, excision partial talus/calcaneus, intraoperative fluoroscopy on 11-mar-2014, limited strength, limited range of motion, impaired gait, chronic bilateral knee pain, limited muscular endurance since 01-jan-2017, hysteroscopy, endometrium (curettage) on 07-feb-2017, addenoid surgery, synvisc for osteoarthritis knee (administered 8-9 months before 22-aug-2017: reduced the pain), knee arthroscopy, abdominal pain, arthritis, dyspareunia, fatigue, tubal ligation, visual disturbance, nausea, frequency, numbness, hematuria, tiredness with difficulty falling back to sleep, periodic limb movement disorder, acute cystitis without hematuria.Family history included alcohol abuse (son), alzheimer's disease, arthritis (father, mother), brain cancer (maternal grandmother), colon cancer (paternal grandmother), depression (brother, mother, son), diabetes, glaucoma (mother), heart disease (mother), high blood pressure: hypertension (mother, father), hyperlipidemia: elevated cholesterol (mother), leukemia (paternal grandfather), myocardial infarction: heart attack (mother), osteoarthritis (father), osteoporosis: thinning of bones (father).Patient had ongoing chronic essential hypertension, chronic depression, chronic polycystic ovarian syndrome (irregular menses, hirsutism, hyperglycemia, possible endometriosis hx, dysmenorrhea, provera use leads to vulvar furuncles), chronic mixed headache syndrome, irritable bowel syndrome since 07-jul-2012, stress incontinence, chronic furuncles since 13-nov-2012, chronic cough since 18-dec-2012, calcaneal spur since 04-mar-2013, chronic hiccoughs since 18-jun-2013, generalized anxiety disorder, unspecified anxiety since 19-jul-2013, equinus deformity of foot, acquired since 25-mar-2013, haglund's deformity since 05-aug-2013, dysphagia since 13-aug-2013, morbid obesity since 07-sep-2013, tachycardia since 07-mar-2014, chronic fatty liver disease, nonalcoholic since 11-mar-2014, restless legs syndrome since 16-sep-2014, chronic back pain since 08-dec-2014, blurry vision (endorses worsening blurry distance vision), colonoscopy w/biopsy, polycystic ovarian disease, plastic surgery, restless leg syndrome, ponv (postoperative nausea and vomiting), chronic allergic rhinitis due to pollen, chronic muscle spasms of lower extremity since 17-mar-2015, primary osteoarthritis of both knees since 14-mar-2016, snoring since 13-feb-2017, achilles tendinitis (right leg contracture, intermittent ankle edema), since 01-may-2017, plantar fascitis, right since 02-may-2017, hypersomnia since 12-jun-2017, gastroesophageal reflux disease, depression, unspecified, occupational disabled, hepatic steatosis, blood sugar increased/hyperglycemia (once around 200), ace inhibitors and zofran allergy (cough due to ace inhibitors, itching with zofran), uncontrolled diabetes mellitus type ii without complication, abscesses in pannus of abdomen, hidradenitis suppurativa vs recurrent mrsa furunculosis, idiopathic peripheral neuropathy (worse in feet, extends to knees worsening over past one and half year), bilateral carpal tunnel syndrome and had surgery for the same, recurrent sneezing, congestion and rhinorrhea, hepatomegaly, diarrhea and constipation due to alternating bowel habits, recurrent numbness and light headedness, mild sensory polyneuropathy.Concomitant medications included paracetamol (tylenol extra-strength); dicycloverine hydrochloride (bentyl); plantago ovata (metamucil); sulfamethoxazole, trimethoprim (bactrim ds); amlodipine besilate (norvasc); bupropion hydrochloride (wellbutrin); buspirone hydrochloride (buspar) for anxiety; celecoxib (celebrex); cetirizine hydrochloride (zyrtec); chlorhexidine gluconate (hibiclens); chlorthalidone; clindamycin phosphate (cleocin t); clonazepam (klonopin) for anxiety; diclofenac sodium (voltaren); esomeprazole sodium (nexium); mometasone furoate (flonase); gabapentin (neurontin); hydrocortisone; losartan potassium (cozaar); metformin hydrochloride (glucophage); potassium chloride (klor-con); pramipexole dihydrochloride (mirapex); and vortioxetine.On 09-nov-2017, the patient started using hylan g-f 20, sodium hyaluronate, intra-articular injection at the dose of 6 ml, once (lot - 7rsl021) for osteoarthritis of left knee.It was reported that complete relief for 1 hour but then worsening pain (latency: 0 day).Patient had some pain and within first week of injection had swelling which improved slightly but had since worsened.Patient stated that the pain was similar now to what it was before the injection (latency: unknown).When joint was painful, patient described as aching, cramping, radiating and sharp marked (major pain with significant limitations) pain.Symptoms have been present for 1 month and has moderately worsened since their previous visit.Pain was aggravated constantly, with normal activities, in bed, bending, using stairs, rising from a chair, at higher levels of activity and without relationship to any activity.Pain is localized to the general lower extremity, medial knee, lateral knee, anterior knee and posterior knee.The patient had tried ice and rest to help with the pain.She has tried celecoxib, ibuprofen, meloxicam (mobic), naproxen, diclofenac sodium and cefixime (flexeril) with no change.Pain was relieved by nothing adequately tried by patient.Patient stated that she received her letter stating a recall of her hylan g-f 20, sodium hyaluronate injection, but she has not had any symptoms described other than continued pain.Patient denies any fevers, nausea, vomiting, or erythematous joint and stated that her swelling had improved.Patient had moderate limping, effusion of 1+ on 12-dec-2017.Patient had trouble walking distances because of the knees and complained of polydipsia (latency: unknown).On 19-apr-2018, patient was diagnosed with iron deficiency anemia (latency: 5 months 10 days).On 30-apr-2018, patient was diagnosed with left midfoot osteoarthritis, left leg mass (latency: 5 months 21 days).On 16-may-2018, patient was diagnosed with cellulitis of left leg.Patient was taking levofloxacin (levaquin) for cellulitis (latency: 6 months 7 days).On 31-may-2018, patient had elevated tsh and t4 (latency: 6 months 22 days).On 01-jun-2018, patient was diagnosed with left plantar fasciitis (latency: 6 months 23 days).On 11-jun-2018, patient reported that the burning was lessened but she now has plantar pain along the long arch and ball of the foot mostly in both feet; left more painful that right.She has increased pain with increased activity.She must use a scooter at the store as she cannot tolerate walking the distance needed to run her errands.On 12-jul-2018, patient presented with suspected bilateral open angle glaucoma, low risk, diagnosed with borderline glaucoma with ocular hypertension, bilateral (latency: 7 months 3 days).On 19-jun-2018, patient was diagnosed with viral upper respiratory tract infection with fatigue, cough, sneezing, body aches, weakness, subjective child, poor appetite, sinus congestion, pain, yellow mucus productive cough with watery eyes and running nose (latency: 7 months 10 days).Patient was advised to have intra-articular glucocorticoid injection but could not do that due to redness and swelling in anterior tibial region which was consistent with cellulitis.By 19-jun-2018, there was no erythema, warmth or any suggestion of skin infection.Patient attributed the mass on the left leg to the hylan g-f 20, sodium hyaluronate injection.The mass had not had any fluctuance, erythema, tenderness or discharge during the many months the mass has been present.She was diagnosed with compartment syndrome (latency: unknown) so a bilateral fasciotomy was performed on 05-feb-2019.On 08-feb-2019, patient reported for follow up and reported that her feet started turning red and started spreading up leg and had a lot of tightness in legs after it.Upon examination, it was noticed that her sutures were healing well and had no signs of infection and had generalized swelling, postoperative tenderness, decreased knee flexion, bilateral, decreased step length, bilateral.Further, she also followed up for her physical therapy for pain.On 13-feb-2019, patient reported again her physical therapy and reported that her symptoms had improved.Patient stated that her legs were real sore today that began saturday and on friday she felt great.She states that she took some of the pills given to her but didn't like how she felt and was trying to take extra strength tylenol.On 15-feb-2019, patient reported again for her bilateral leg pain and stated her shins have mainly been painful around her incision.She stated most of her presurgical complaints had resolved.On 19-feb-2019, for physical therapy for her right ankle/foot and symptoms had improved and she was doing massages and ankle motions at home.On 22-feb-2019, the patients had her routine physical therapy session for her pain and reported that her condition was improving.She rated her pain 2 on a scale of 10 and stated that it was continuous in nature.The patient was given instructions regarding home exercises.On 26-feb-2019, patient reported for follow up of her pain and rated it 1 on a scale of 10 and stated that her condition continues to improve, although she was a little concerned about her wounds as the steristrips kept ripping off when putting on compression socks.Upon examination, it was observed that her incisions were healing with no sign of infection.Corrective treatment: levofloxacin for cellulitis of left leg/left tibial cellulitis, ibuprofen, codeine phosphate, guaifenesin, otc nasal saline wash for viral uri with cough, unspecified, metformin for trouble walking distances/limping, ice, naproxen, meloxicam, cefixime, ibuprofen and rest for some pain/localized to medial, lateral, anterior and posterior knee/joint painful, described pain as aching, cramping, radiating, sharp; aggravated constantly, with normal activities, in bed, bending, using stairs, rising from a chair at higher levels of activity; bilateral fasciotomy for compartment syndrome; not reported for rest outcome: not recovered for cellulitis of left leg/left tibial cellulitis, iron deficiency anemia, plantar fasciitis, left, viral uri with cough, unspecified, osteoarthritis left mid foot, some pain/localized to medial, lateral, anterior and posterior knee/joint painful, described pain as aching, cramping, radiating, sharp, device malfunction, aggravated constantly, with normal activities, in bed, bending, using stairs, rising from a chair at higher levels of activity; recovering for some swelling, recovered for effusion left knee 1+, recovering for pain localized to the general lower extremity to pain localized to the general lower extremity/legs are real sore/bilateral leg pain; unknown for rest a product technical complaint (ptc) was initiated on 05-mar-2019 for synvisc one.Batch number: 7rsl021, global ptc number: 57484.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 is completed, corrective and preventive actions would be implemented.Seriousness criteria: medically significant for device malfunction, open angle glaucoma, suspected low risk bilateral/borderline glaucoma with ocular hypertension, bilateral, cellulitis of left leg/left tibial cellulitis, compartment syndrome additional information was received on 05-mar-2019.Global ptc number was added.No significant information added.Additional information received on 05-apr-2019 from lawyer.Medical history of colonoscopy w/biopsy, polycystic ovarian disease, plastic surgery, restless leg syndrome, ponv (postoperative nausea and vomiting) added.Event of compartment syndrome added with symptoms of a lot of tightness in legs and feet started turning red and started spreading up leg added.Event verbatim updated from trouble walking distances/limping to trouble walking distances/limping/impaired gait and pain localized to the general lower extremity to pain localized to the general lower extremity/legs are real sore/bilateral leg pain and outcome was updated to recovering.
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