| Lot Number 7RSL021 |
| Device Problems
Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Pain (1994); Thrombosis (2100); Weakness (2145); Hypoesthesia, Foot/Leg (2354); Arthralgia (2355); Joint Swelling (2356); Numbness (2415); No Code Available (3191)
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| Event Date 11/01/2017 |
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Event Type
Injury
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Event Description
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Dvt (deep vein thrombosis)/ 2 clots in lower leg [deep vein thrombosis] ; compression neuropathy [nerve compression] ([unilateral leg pain], [numbness in leg], [weakness], [paresthesia foot]); plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot [plantar fasciitis] ; limited on daily activities [activities of daily living impaired] ; walker user [walker user].Case narrative: initial information received on (b)(6) 2018 regarding an unsolicited valid serious case received from a physician and patient from united states.This case involves a (b)(6) male patient, who developed dvt (deep vein thrombosis)/ 2 clots in lower leg, compression neuropathy, plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot, limited on daily activities and was a walker user (latency: unknown for all), after he was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history/ concurrent conditions included myalgia (due to statins), myositis, hyperlipidaemia, hypothyroidism, bronchitis, onychomycosis of toe nail, fever, acute sinusitis, snoring, back pain, leukocytosis, stress, fatigue, anxiety, rectal cancer with rectal cancer surgery (1980), appendicectomy, tonsillectomy, 5 right elbow surgeries from crushing injury, back surgery, depression, lack of physical exercise, inappropriate diet and eating habits, overweight and obesity.Patient is a former smoker (quit 22 years ago) and never drinks alcohol.The patient's father had hypertension, diabetes mellitus and alzheimer's disease.Patient's mother had hypertension, diabetes mellitus and breast cancer.Concomitant medications included levothyroxine sodium, pantoprazole sodium, citalopram hydrobromide, metoprolol tartrate,acetylsalicylic acid (aspirin), chondroitin sulfate, glucosamine hydrochloride (osteo bi-flex), cascara sagrada (rhamnus purshiana), bacopa monnieri herb, camellia sinensis leaf, curcuma longa rhizome, silybum marianum seed, withania somnifera root (protandim), gabapentin and apixaban (eliquis).On (b)(6) 2017, the patient was treated with hylan g-f 20, sodium hyaluronate injection, via intra-articular route (dose: not provided) for unknown indication.It was reported that a nerve in knee was evidently hit and 2 clots developed in the lower leg.On an unknown date of (b)(6) 2017, after unknown latency, the patient developed a serious dvt (deep vein thrombosis).This event was assessed as medically significant.Secondary to this, the patient developed a non-serious compression neuropathy, associated with left leg pain and severe pain from the knee down to the foot (pain in extremity); numbness in leg and foot (hypoaesthesia); paresthesia of foot and burning sensation in ball of left foot (paraesthesia) and weakness (asthenia).The patient developed a non-serious sharp shooting severe pain in bottom of foot and hypersensitivity of planter surface of foot (plantar fasciitis).The pain affected the left foot and ankle and was not associated with swelling.The patient's daily activities got limited and became a walker user.On (b)(6) 2017, patient reported he had return of feeling except in bottom of left foot.On (b)(6) 2018, patient was now overall better and pain was better.On (b)(6) 2018, it was reported that patient no longer had sharp, shooting pain in foot, paresthesia continued to diminish and symptoms were more of plantar fasciitis.On (b)(6) 2018, patient reported that sensation in lower leg and foot was returning but the heel was still numb.On (b)(6) 2018, patient reported significantly decreased hypersensitivity of planter surface of foot and said that rubbing bottom of foot with various surfaces had decreased the intensity of sharp pains.Final diagnosis was walker user, severe plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot, compression neuropathy, dvt (deep vein thrombosis)/ 2 clots in lower leg and limited on daily activities.The patient was treated with gabapentin (neurontin) compression neuropathy; apixaban (eliquis) for deep vein thrombosis; gait training for being a walker user; manual therapy, whirlpool/ fluid therapy, therapeutic exercises for paresthesia of foot/ burning sensation in ball of left foot; anticoagulants (eliquis) for 3 months for dvt (deep vein thrombosis).The outcome was reported as recovering / resolving for compression neuropathy, as recovering / resolving for left leg pain/ severe pain from the knee down to the foot, as recovering / resolving for numbness in leg and foot, as unknown for weakness and for dvt (deep vein thrombosis)/ 2 clots in lower leg, as recovering / resolving for plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot, as recovering / resolving for limited on daily activities, as recovering / resolving for paresthesia of foot/ burning sensation in ball of left foot and as recovered / resolved on an unknown date for walker user.Seriousness criteria: medically significant event of dvt (deep vein thrombosis).A product technical complaint (ptc) was initiated on 12-sep-2018 for "synvisc one".Batch number unknown, global ptc number: (b)(4).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.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date was (b)(6) 2018.No safety issues were indicated in this review.Additional information was received in the form of investigation summary on 12-sep-2018.Ptc results and number was added.
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Event Description
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Device malfunction [device malfunction] dvt (deep vein thrombosis)/ 2 clots in lower leg [deep vein thrombosis] ([pain upon movement], [pain in extremity]) walker user [walker user] compression neuropathy [nerve compression] ([peripheral neuropathic pain], [numbness in leg], [weakness], [paresthesia foot]) plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot [plantar fasciitis] limited on daily activities [activities of daily living impaired] gait antalgic [gait disturbance] grossly limited with pain [joint range of motion decreased] grossly limited with pain [pain upon movement] pain/medial joint line tenderness [knee pain] unilateral swelling [joint swelling] case narrative: initial information received on 05-sep-2018 regarding an unsolicited valid serious case received from a physician and patient from united states.This case involves a 72 years old male patient, who developed dvt (deep vein thrombosis)/ 2 clots in lower leg, compression neuropathy, plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot, limited on daily activities and was a walker user, gait antalgic, pain/medial joint line tenderness, unilateral swelling and grossly limited with pain (latency: unknown for all), after he was treated with hylan g-f 20, sodium hyaluronate (synvisc one).Additionally, the event of device malfunction was also reported.The patient's past medical history/ concurrent conditions included myalgia (due to statins), myositis, hyperlipidaemia, hypothyroidism, bronchitis, onychomycosis of toe nail, fever, acute sinusitis, snoring, back pain, leukocytosis, stress, fatigue, anxiety, rectal cancer with rectal cancer surgery (1980), appendicectomy, tonsillectomy, 5 right elbow surgeries from crushing injury, back surgery, depression, lack of physical exercise, inappropriate diet and eating habits, overweight, obesity, simvastatin allergy, bilateral carotid disease, bicuspid aortic valve, aortic valve stenosis, dyslipidemia, mitral valve disorder, tricuspid valve disorders, non-rheumatic, shoulder surgery, peripheral neuropathy, hernia repair, gerd, plantar fasciitis, left leg dvt and cardiac edema.Patient is a former smoker (quit 22 years ago) and never drinks alcohol.The patient's father had hypertension, diabetes mellitus, alzheimer's disease and dyslipidemia.Patient's mother had hypertension, diabetes mellitus, dyslipidemia, hypotension and breast cancer.His sister had diabetes mellitus.Concomitant medications included levothyroxine sodium, pantoprazole sodium (protonix), citalopram hydrobromide (celexa), metoprolol tartrate (lopressor), acetylsalicylic acid (ecotrin), chondroitin sulfate, glucosamine hydrochloride (osteo bi-flex), cascara sagrada (rhamnus purshiana), bacopa monnieri herb, camellia sinensis leaf, curcuma longa rhizome, silybum marianum seed, withania somnifera root (protandim), gabapentin, apixaban (eliquis), spironolactone (aldactone) and fish oil.On (b)(6)2017, the patient was treated with hylan g-f 20, sodium hyaluronate injection, via intra-articular route (lot number: 7rsl021) for bilateral knee osteoarthritis.It was reported that a nerve in knee was evidently hit and 2 clots developed in the lower leg.On an unknown date of (b)(6)2017, after unknown latency, the patient developed a serious dvt (deep vein thrombosis).This event was assessed as medically significant.Secondary to this, the patient developed a non-serious compression neuropathy, associated with left leg pain and severe pain from the knee down to the foot (pain in extremity); numbness in leg and foot (hypoaesthesia); paresthesia of foot and burning sensation in ball of left foot (paraesthesia) and weakness (asthenia).The patient developed a non-serious sharp shooting severe pain in bottom of foot and hypersensitivity of planter surface of foot (plantar fasciitis).The pain affected the left foot and ankle and was not associated with swelling.The patient's daily activities got limited and became a walker user.On (b)(6)2017, patient presented in the healthcare facility and stated that had significant pain in thigh, the calf and knee area was in emergency room around (b)(6)2017 and ultimately diagnosed with left lower extremity and was placed om some medication after admission, patient gradually improved in the thigh and the calf, but the left foot was numb.On the same day, patient had blood pressure of 142/78 mmhg.On (b)(6)2017, patient reported he had return of feeling except in bottom of left foot.On (b)(6)2018, patient was now overall better and pain was better.On the same day, his cholesterol level was 213 mg/dl (high), creatinine was 1.37 mg/dl (high), gfr was 51 (low) and ldl was 147 mg/dl (high).On (b)(6)2018, his blood pressure was 106/65 mmhg (low) and pulse rate was 91 (high).On (b)(6)2018, cholesterol was 202 mg/dl (high), ldl was 161 mg/dl (high) and non-hdl was 162 mg/dl (high).On (b)(6)2018, it was reported that patient no longer had sharp, shooting pain in foot, paresthesia continued to diminish and symptoms were more of plantar fasciitis.During his visit on (b)(6)2018 in the hospital, he was observed with pain 6.0-6/10 pain.He was also observed with mildly gait antalgic.In his both knees, medial joint line tenderness was observed.It was also observed that both knees were grossly limited and with pain.On (b)(6)2018, patient reported that sensation in lower leg and foot was returning but the heel was still numb.On (b)(6)2018, patient reported significantly decreased hypersensitivity of planter surface of foot and said that rubbing bottom of foot with various surfaces had decreased the intensity of sharp pains.Final diagnosis was walker user, severe plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot, compression neuropathy, dvt (deep vein thrombosis)/ 2 clots in lower leg and limited on daily activities.Corrective treatment: gabapentin (neurontin) compression neuropathy; apixaban (eliquis) for deep vein thrombosis; gait training for being a walker user; manual therapy, whirlpool/ fluid therapy, therapeutic exercises for paresthesia of foot/ burning sensation in ball of left foot; anticoagulants (eliquis) for 3 months for dvt (deep vein thrombosis).Outcome: recovering / resolving for compression neuropathy, plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot, limited on daily activities; unknown for weakness and for dvt (deep vein thrombosis)/ 2 clots in lower leg, gait antalgic and grossly limited with pain; recovered / resolved for walker user.Seriousness criteria: medically significant and intervention required for the event of dvt (deep vein thrombosis) and disability for walker user a product technical complaint (ptc) was initiated on (b)(6)2018 for "synvisc one".Batch number: 7rsl021, global ptc number: (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Additional information was received in the form of investigation summary on 13-sep-2018.Ptc results and number was added.Upon internal review on (b)(6)2019 processed with clock start date of (b)(6)2018 the malfunction field previously captured as yes was removed.Additional information was received on 19-feb-2019 from the lawyer.Events of gait antalgic, pain/ pain/medial joint line tenderness, unilateral swelling and grossly limited with pain were added.Additionally, the event of device malfunction was added.Medical history of the patient was updated by adding simvastatin allergy, bilateral carotid disease, bicuspid aortic valve, aortic valve stenosis, dyslipidemia, mitral valve disorder, tricuspid valve disorders, non-rheumatic, shoulder surgery, peripheral neuropathy, hernia repair, gerd and plantar fasciitis.Patient's family's medical history was added.Concomitant medication updated.Lab results were added.Indication was added.Clinical course updated.Text amended accordingly.
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Event Description
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Dvt (deep vein thrombosis)/ 2 clots in lower leg [deep vein thrombosis] compression neuropathy [nerve compression] ([unilateral leg pain], [numbness in leg], [paresthesia foot], [weakness]) plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot [plantar fasciitis] limited on daily activities [activities of daily living impaired] walker user [walker user] case narrative: initial information received on 05-sep-2018 regarding an unsolicited valid serious case received from a physician and patient from united states.This case involves a 72 years old male patient, who developed dvt (deep vein thrombosis)/ 2 clots in lower leg, compression neuropathy, plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot, limited on daily activities and was a walker user (latency: unknown for all), after he was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history concurrent conditions included myalgia (due to statins), myositis, hyperlipidaemia, hypothyroidism, bronchitis, onychomycosis of toe nail, fever, acute sinusitis, snoring, back pain, leukocytosis, stress, fatigue, anxiety, rectal cancer with rectal cancer surgery (1980), appendicectomy, tonsillectomy, 5 right elbow surgeries from crushing injury, back surgery, depression, lack of physical exercise, inappropriate diet and eating habits, overweight and obesity.Patient is a former smoker (quit 22 years ago) and never drinks alcohol.The patient's father had hypertension, diabetes mellitus and alzheimer's disease.Patient's mother had hypertension, diabetes mellitus and breast cancer.Concomitant medications included levothyroxine sodium, pantoprazole sodium, citalopram hydrobromide, metoprolol tartrate,acetylsalicylic acid (aspirin), chondroitin sulfate, glucosamine hydrochloride (osteo bi-flex), cascara sagrada (rhamnus purshiana), bacopa monnieri herb, camellia sinensis leaf, curcuma longa rhizome, silybum marianum seed, withania somnifera root (protandim), gabapentin and apixaban (eliquis).On (b)(6) 2017 , the patient was treated with hylan g-f 20, sodium hyaluronate injection, via intra-articular route (dose: not provided) for unknown indication.It was reported that a nerve in knee was evidently hit and 2 clots developed in the lower leg.On an unknown date of (b)(6) 2017 , after unknown latency, the patient developed a serious dvt (deep vein thrombosis).This event was assessed as medically significant.Secondary to this, the patient developed a non-serious compression neuropathy, associated with left leg pain and severe pain from the knee down to the foot (pain in extremity); numbness in leg and foot (hypoaesthesia); paresthesia of foot and burning sensation in ball of left foot (paraesthesia) and weakness (asthenia).The patient developed a non-serious sharp shooting severe pain in bottom of foot and hypersensitivity of planter surface of foot (plantar fasciitis).The pain affected the left foot and ankle and was not associated with swelling.The patient's daily activities got limited and became a walker user.On (b)(6) 2017, patient reported he had return of feeling except in bottom of left foot.On (b)(6) 2018, patient was now overall better and pain was better.On(b)(6) 2018, it was reported that patient no longer had sharp, shooting pain in foot, paresthesia continued to diminish and symptoms were more of plantar fasciitis.On (b)(6) 2018, patient reported that sensation in lower leg and foot was returning but the heel was still numb.On 05-sep-2018, patient reported significantly decreased hypersensitivity of planter surface of foot and said that rubbing bottom of foot with various surfaces had decreased the intensity of sharp pains.Final diagnosis was walker user, severe plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot, compression neuropathy, dvt (deep vein thrombosis)/ 2 clots in lower leg and limited on daily activities.The patient was treated with gabapentin (neurontin) compression neuropathy; apixaban (eliquis) for deep vein thrombosis; gait training for being a walker user; manual therapy, whirlpool/ fluid therapy, therapeutic exercises for paresthesia of foot/ burning sensation in ball of left foot; anticoagulants (eliquis) for 3 months for dvt (deep vein thrombosis).The outcome was reported as recovering / resolving for compression neuropathy, as recovering / resolving for left leg pain/ severe pain from the knee down to the foot, as recovering / resolving for numbness in leg and foot, as unknown for weakness and for dvt (deep vein thrombosis)/ 2 clots in lower leg, as recovering / resolving for plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot, as recovering / resolving for limited on daily activities, as recovering / resolving for paresthesia of foot/ burning sensation in ball of left foot and as recovered / resolved on an unknown date for walker user.Seriousness criteria: medically significant event of dvt (deep vein thrombosis).A product technical complaint (ptc) was initiated on 12-sep-2018 for "synvisc one".Batch number unknown, global ptc number: 55451.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.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date was 13-sep-2018.No safety issues were indicated in this review.Additional information was received in the form of investigation summary on 13-sep-2018.Ptc results and number was added.Upon internal review on 09-jan-2019 processed with clock start date of 13-sep-2018 the malfunction field previously captured as yes was removed.
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Event Description
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Device malfunction [device malfunction] dvt (deep vein thrombosis)/ 2 clots in lower leg [deep vein thrombosis] ([pain upon movement], [pain in extremity]) walker user [walker user] compression neuropathy [nerve compression] ([peripheral neuropathic pain], [numbness in leg], [weakness], [paresthesia foot]) plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot [plantar fasciitis] limited on daily activities [activities of daily living impaired] grossly limited with pain [joint range of motion decreased] grossly limited with pain [pain upon movement] gait antalgic [gait disturbance] pain/medial joint line tenderness [knee pain] unilateral swelling [joint swelling].Case narrative: upon internal review on 12-jul-2019 processed with clock start date of 01-mar-2019, the case would be prepared for deletion and the information would be merged in case 2018sa024513.Initial information received on 05-sep-2018 regarding an unsolicited valid serious case received from a physician and patient from united states.This case involves a 72 years old male patient, who developed dvt (deep vein thrombosis)/ 2 clots in lower leg, compression neuropathy, plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot, limited on daily activities and was a walker user, gait antalgic, pain/medial joint line tenderness, unilateral swelling and grossly limited with pain (latency: unknown for all), after he was treated with hylan g-f 20, sodium hyaluronate (synvisc one).Additionally, the event of device malfunction was also reported.The patient's past medical history/ concurrent conditions included myalgia (due to statins), myositis, hyperlipidaemia, hypothyroidism, bronchitis, onychomycosis of toe nail, fever, acute sinusitis, snoring, back pain, leukocytosis, stress, fatigue, anxiety, rectal cancer with rectal cancer surgery (1980), appendicectomy, tonsillectomy, 5 right elbow surgeries from crushing injury, back surgery, depression, lack of physical exercise, inappropriate diet and eating habits, overweight, obesity, simvastatin allergy, bilateral carotid disease, bicuspid aortic valve, aortic valve stenosis, dyslipidemia, mitral valve disorder, tricuspid valve disorders, non-rheumatic, shoulder surgery, peripheral neuropathy, hernia repair, gerd, plantar fasciitis, left leg dvt and cardiac edema.Patient is a former smoker (quit 22 years ago) and never drinks alcohol.The patient's father had hypertension, diabetes mellitus, alzheimer's disease and dyslipidemia.Patient's mother had hypertension, diabetes mellitus, dyslipidemia, hypotension and breast cancer.His sister had diabetes mellitus.Concomitant medications included levothyroxine sodium, pantoprazole sodium (protonix), citalopram hydrobromide (celexa), metoprolol tartrate (lopressor), acetylsalicylic acid (ecotrin), chondroitin sulfate, glucosamine hydrochloride (osteo bi-flex), cascara sagrada (rhamnus purshiana), bacopa monnieri herb, camellia sinensis leaf, curcuma longa rhizome, silybum marianum seed, withania somnifera root (protandim), gabapentin, apixaban (eliquis), spironolactone (aldactone) and fish oil.On (b)(6) 2017 the patient was treated with hylan g-f 20, sodium hyaluronate injection, via intra-articular route (lot number: 7rsl021) for bilateral knee osteoarthritis.It was reported that a nerve in knee was evidently hit and 2 clots developed in the lower leg.On an unknown date of nov-2017, after unknown latency, the patient developed a serious dvt (deep vein thrombosis).This event was assessed as medically significant.Secondary to this, the patient developed a non-serious compression neuropathy, associated with left leg pain and severe pain from the knee down to the foot (pain in extremity); numbness in leg and foot (hypoaesthesia); paresthesia of foot and burning sensation in ball of left foot (paraesthesia) and weakness (asthenia).The patient developed a non-serious sharp shooting severe pain in bottom of foot and hypersensitivity of planter surface of foot (plantar fasciitis).The pain affected the left foot and ankle and was not associated with swelling.The patient's daily activities got limited and became a walker user.On (b)(6) 2017 , patient presented in the healthcare facility and stated that had significant pain in thigh, the calf and knee area was in emergency room around (b)(6) 2017 and ultimately diagnosed with left lower extremity and was placed om some medication after admission, patient gradually improved in the thigh and the calf, but the left foot was numb.On the same day, patient had blood pressure of 142/78 mmhg.On 18-dec-2017, patient reported he had return of feeling except in bottom of left foot.On (b)(6) 2018 patient was now overall better and pain was better.On the same day, his cholesterol level was 213 mg/dl (high), creatinine was 1.37 mg/dl (high), gfr was 51 (low) and ldl was 147 mg/dl (high).On (b)(6) 2018 his blood pressure was 106/65 mmhg (low) and pulse rate was 91 (high).On (b)(6) 2018 cholesterol was 202 mg/dl (high), ldl was 161 mg/dl (high) and non-hdl was 162 mg/dl (high).On (b)(6) 2018 it was reported that patient no longer had sharp, shooting pain in foot, paresthesia continued to diminish and symptoms were more of plantar fasciitis.During his visit on (b)(6) 2018 in the hospital, he was observed with pain 6.0-6/10 pain.He was also observed with mildly gait antalgic.In his both knees, medial joint line tenderness was observed.It was also observed that both knees were grossly limited and with pain.On (b)(6) 2018 patient reported that sensation in lower leg and foot was returning but the heel was still numb.On (b)(6) 2018 patient reported significantly decreased hypersensitivity of planter surface of foot and said that rubbing bottom of foot with various surfaces had decreased the intensity of sharp pains.Final diagnosis was walker user, severe plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot, compression neuropathy, dvt (deep vein thrombosis)/ 2 clots in lower leg and limited on daily activities.Corrective treatment: gabapentin (neurontin) compression neuropathy; apixaban (eliquis) for deep vein thrombosis; gait training for being a walker user; manual therapy, whirlpool/ fluid therapy, therapeutic exercises for paresthesia of foot/ burning sensation in ball of left foot; anticoagulants (eliquis) for 3 months for dvt (deep vein thrombosis).Outcome: recovering / resolving for compression neuropathy, plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot, limited on daily activities; unknown for weakness and for dvt (deep vein thrombosis)/ 2 clots in lower leg, gait antalgic and grossly limited with pain; recovered / resolved for walker user.Seriousness criteria: medically significant and intervention required for the event of dvt (deep vein thrombosis) and disability for walker user.A product technical complaint (ptc) was initiated on (b)(6) 2018 for "synvisc one".Batch number: 7rsl021, global ptc number: 55451.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 in the form of investigation summary on 13-sep-2018.Ptc results and number was added.Upon internal review on 09-jan-2019 processed with clock start date of 13-sep-2018 the malfunction field previously captured as yes was removed.Additional information was received on 19-feb-2019 from the lawyer.Events of gait antalgic, pain/ pain/medial joint line tenderness, unilateral swelling and grossly limited with pain were added.Additionally, the event of device malfunction was added.Medical history of the patient was updated by adding simvastatin allergy, bilateral carotid disease, bicuspid aortic valve, aortic valve stenosis, dyslipidemia, mitral valve disorder, tricuspid valve disorders, non-rheumatic, shoulder surgery, peripheral neuropathy, hernia repair, gerd and plantar fasciitis.Patient's family's medical history was added.Concomitant medication updated.Lab results were added.Indication was added.Clinical course updated.Text amended accordingly.Follow up information received on 01-mar-2019.No new information.Upon internal review on 12-jul-2019 processed with clock start date of 01-mar-2019, the case would be prepared for deletion and the information would be merged in case (b)(4) as the case (b)(4) was found to be a duplicate of (b)(4).
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