| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Hypersensitivity/Allergic reaction (1907); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); Ambulation Difficulties (2544); No Code Available (3191); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
| Event Date 10/01/2019 |
|
Event Type
Injury
|
|
Event Description
|
|
Difficulty standing [difficulty in standing].Could not walk [unable to walk].Severe swelling [swelling of l knee].In a lot of pain [aching (l) knee].Case narrative: this case is linked to (b)(4) (multiple devices, right knee).Initial information received on 18-oct-2019 from united states regarding an unsolicited valid serious case received from a patient via call.This case involves a (b)(6) year old female patient who experienced in a lot of pain (latency: 3 weeks), severe swelling (latency: 3 weeks), difficulty standing (latency: 3 weeks) and could not walk (latency: few weeks) after being treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included severe reactions to other medications.The past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.Before this, she received regular cortisone injections in her knees.On (b)(6) 2019, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate (synvisc one) her left knee at dosage of 6ml, frequency once (batch: unknown) for bilateral knee oa (osteoarthritis) by her physician.Information for batch number was requested.Reportedly, this was the first time she had ever received synvisc-one.On an unknown date in (b)(6) 2019, three weeks after the injection, the patient had severe swelling, and difficulty standing.These events were assessed as serious as they required intervention.Then 2 days later, patient experienced she could not walk and had to use a wheelchair.This event was assessed as serious as it was leading to disability and required intervention.She went to the emergency ortho clinic in her new town and was told by the doctor that there was no way that the reaction could be due to synvisc-one since it was delayed by three weeks.As a corrective treatment for all the events, patient received cortisone injection and 24 hours later found much relief.She also used paracetamol (advil), and ice packs.After the cortisone injection, her swelling decreased enough, and she could walk again but she was still in a lot of pain.She mentioned that her husband said her knees looked hideous.Patient believed that her reaction could be from synvisc-one as she had severe reactions to other medications in the past.On (b)(6) 2019 (tuesday), patient was scheduled to visit her doctor.Action taken: not applicable for all events.Corrective treatment: advil, ice pack, cortisone injection for severe swelling, difficulty standing, could not walk and in a lot of pain; wheelchair for could not walk outcome: recovering for severe swelling, and could not walk; unknown for difficulty standing; not recovered for a lot of pain a product technical complaint was initiated and results were pending for the same.
|
| |
|
Event Description
|
|
Difficulty standing [difficulty in standing].Could not walk/ difficulty walking [unable to walk].Difficult to weight bear [weight bearing difficulty].Severe swelling [swelling of l knee].In a lot of pain [aching (l) knee] ([pain upon movement]).Could be allergic reaction to injection [allergic reaction].Case narrative: this case was linked to 2019sa290757 (multiple devices, right knee).Initial information received on 18-oct-2019 from united states regarding an unsolicited valid serious case received from a patient via call.This case involves a 58 year old female patient (58 kgs and 165 cm) who experienced in a lot of pain (latency: 3 weeks), severe swelling (latency: 3 weeks), difficulty standing, difficult to weight bear (latency: 3 weeks), could be allergic reaction to injection and could not walk/ difficulty walking (latency: few weeks) after being treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included severe reactions to other medications, irritable bowel syndrome, breast mass removal, cervical discectomy, cesarean, gall bladder, hysterectomy, lt wrist/hand surgery, lung biopsy, sinus surgery, right knee surgery, chondral calcinosis, myocardial infarction, left knee injury, back problems.Patients ongoing conditions included chronic pneumonia, bilateral knee pain, allergies to carta xt, felodipine, morphine, nitroglycerin and valsartan, allergy to sulfa with reactions: cartia xt: rash, felodipine: respiratory distress, morphine: itching, nitroglycerin: seizure and valsartan: cough, no tobacco use and alcohol use.The past medical treatment(s), vaccination(s), family history were not provided.Before this, she received regular cortisone injections in her knees.Concomitant medications included biotin; clonidine; montelukast sodium; omeprazole; diclofenac sodium (pennsaid); calcium 500 + d3; aspirin 81, ranolazine (ranolazine extended release); spironolactone; budesonide, formoterol fumarate (symbicort); fluticasone propionate, salmeterol (wixela inhub); and cetirizine hydrochloride (zyrtec [cetirizine hydrochloride]).On (b)(6) 2019, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate (synvisc one) in her left knee at dosage of 6ml, frequency once (batch: unknown) for bilateral primary osteoarthritis of knee by her physician.Information for batch number was requested.Reportedly, this was the first time she had ever received synvisc-one.On an unknown date on (b)(6) 2019, three weeks after the injection, the patient had severe swelling, and difficulty standing and difficult to weight bear.These events were assessed as serious as they required intervention.Then 2 days later, patient experienced she could not walk and had to use a wheelchair.This event was assessed as serious as it was leading to disability and required intervention.She went to the emergency ortho clinic in her new town and was told by the doctor that there was no way that the reaction could be due to synvisc-one since it was delayed by three weeks.The patient thought she was having allergic reaction.Treatment for all the events, patient received cortisone injection and 24 hours later found much relief.She also used paracetamol (advil), and ice packs.After the cortisone injection, her swelling decreased enough, and she could walk again but she was still in a lot of pain.The patient states her knee pain is so severe she is having difficulty walking.The patient denies being unstable.She describes the pain as sharp, worse when trying to bend the knees or place weight on them, better at rest.She mentioned that her husband said her knees looked hideous.Patient believed that her reaction could be from synvisc-one as she had severe reactions to other medications in the past.On (b)(6) 2019, patient visited her physician and was her knee was cleaned with betadine, after which 4 cc of marcaine 0.25% and 1cc kenalog 40 mg was injected and then covered with sterile dressing.Patient tolerated the procedure well without complications.Patient was advised to limit activities to comfort level, apply ice to the area and rest to allow healing to occur.She was advised to call or return to the office if area of injection became painfully symptomatic or looked infected.On (b)(6) 2019 (tuesday), patient was scheduled to visit her doctor.On 11-dec-2019, patient reported for follow up of her bilateral knee pain.Patient complained of 1/10 pain in knees.Patient could not be given nsaids as she had an episode of myocardial infarction recently.The patient was prescribed voltaren gel to apply in the affected area.The patient was scheduled to follow up on (b)(6) 2020 to consider getting cortisone injections.Action taken: not applicable for all events.Corrective treatment: advil, ice pack, volaren gel, kenalog, cortisone injection for severe swelling, difficulty standing, could not walk and in a lot of pain; wheelchair for could not walk/ difficulty walking.Outcome: recovering for severe swelling, and could not walk/ difficulty walking; unknown for difficulty standing, difficult to weight bear and could be allergic reaction to injection; not recovered for a lot of pain.A product technical complaint was initiated and results were pending for the same.Additional information received on (b)(6) 2019 from consumer.Patient weight, race, ethnicity and height added.History of bilateral knee pain, chronic pneumonia, irritable bowel syndrome, breast mass removal, cervical discectomy, cesarean, gall bladder, hysterectomy, lt wrist/hand surgery, lung biopsy, sinus surgery, right knee surgery, left knee injury, back problems, allergies to carta xt, felodipine, morphine, nitroglycerin and valsartan, allergy to sulfa, no tobacco use and alcohol use.Concomitant medications included biotin, clonidine, montelukast sodium, omeprazole, pennsaid, ranolazine, spironolactone, symbicort, wixela and zyrtec.Suspect product indication updated.Clinical course updated.Text amended accordingly.
|
| |
|
Event Description
|
|
Difficulty standing [difficulty in standing] could not walk/ difficulty walking [unable to walk] difficult to weight bear [weight bearing difficulty] severe swelling [swelling of l knee] in a lot of pain [aching (l) knee] ([pain upon movement]) could be allergic reaction to injection [allergic reaction] case narrative: this case was linked to (b)(4) (multiple devices, right knee) initial information received on 18-oct-2019 from united states regarding an unsolicited valid serious case received from a patient via call.This case involves a (b)(6) female patient (58 kgs and 165 cm) who experienced in a lot of pain (latency: 3 weeks), severe swelling (latency: 3 weeks), difficulty standing, difficult to weight bear (latency: 3 weeks), could be allergic reaction to injection and could not walk/ difficulty walking (latency: few weeks) after being treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included severe reactions to other medications, irritable bowel syndrome, breast mass removal, cervical discectomy, cesarean, gall bladder, hysterectomy, lt wrist/hand surgery, lung biopsy, sinus surgery, right knee surgery, chondral calcinosis, myocardial infarction, left knee injury, back problems.Patients ongoing conditions included chronic pneumonia, bilateral knee pain, allergies to carta xt, felodipine, morphine, nitroglycerin and valsartan, allergy to sulfa with reactions: cartia xt: rash, felodipine: respiratory distress, morphine: itching, nitroglycerin: seizure and valsartan: cough.The patient had no tobacco use and alcohol use.The past medical treatment(s), vaccination(s), family history were not provided.Before this, she received regular cortisone injections in her knees.Concomitant medications included biotin; clonidine; montelukast sodium; omeprazole; diclofenac sodium (pennsaid); calcium 500 + d3; aspirin 81, ranolazine (ranolazine extended release); spironolactone; budesonide, formoterol fumarate (symbicort); fluticasone propionate, salmeterol (wixela inhub); and cetirizine hydrochloride (zyrtec [cetirizine hydrochloride]).On (b)(6) 2019, the patient received intra-articular injection, liquid (solution) of hylan g-f 20, sodium hyaluronate (synvisc one) in her left knee at dosage of 6ml, frequency once (batch: unknown; strength: 48 mg/6 ml) for bilateral primary osteoarthritis of knee by her physician.Information for batch number was requested.Reportedly, this was the first time she had ever received synvisc-one.On an unknown date in (b)(6) 2019, three weeks after the injection, the patient had severe swelling (joint swelling), and difficulty standing (dysstasia) and difficult to weight bear (weight bearing difficulty).These events were assessed as serious as they required intervention.Then 2 days later, patient experienced she could not walk (gain inability) and had to use a wheelchair.This event was assessed as serious as it was leading to disability and required intervention.She went to the emergency ortho clinic in her new town and was told by the doctor that there was no way that the reaction could be due to synvisc-one since it was delayed by three weeks.The patient thought she was having allergic reaction (hypersensitivity).Treatment for all the events, patient received cortisone injection and 24 hours later found much relief.She also used paracetamol (advil), and ice packs.After the cortisone injection, her swelling decreased enough, and she could walk again but she was still in a lot of pain (arthralgia).The patient states her knee pain is so severe she is having difficulty walking.The patient denies being unstable.She describes the pain as sharp, worse when trying to bend the knees (pain) or place weight on them, better at rest.She mentioned that her husband said her knees looked hideous.Patient believed that her reaction could be from synvisc-one as she had severe reactions to other medications in the past.On (b)(6) 2019, patient visited her physician and was her knee was cleaned with betadine, after which 4 cc of marcaine 0.25% and 1cc kenalog 40 mg was injected and then covered with sterile dressing.Patient tolerated the procedure well without complications.Patient was advised to limit activities to comfort level, apply ice to the area and rest to allow healing to occur.She was advised to call or return to the office if area of injection became painfully symptomatic or looked infected.On (b)(6) 2019 (tuesday), patient was scheduled to visit her doctor.On (b)(6) 2019, patient reported for follow up of her bilateral knee pain.Patient complained of 1/10 pain in knees.Patient could not be given nsaids as she had an episode of myocardial infarction recently.The patient was prescribed voltaren gel to apply in the affected area.The patient was scheduled to follow up in (b)(6) 2020 to consider getting cortisone injections action taken: not applicable for all events corrective treatment: advil, ice pack, volaren gel, kenalog, cortisone injection for severe swelling, difficulty standing, could not walk and in a lot of pain; wheelchair for could not walk/ difficulty walking outcome: recovering for severe swelling, and could not walk/ difficulty walking; unknown for difficulty standing, difficult to weight bear and could be allergic reaction to injection; not recovered for a lot of pain a product technical complaint (ptc) was initiated on 17-oct-2019 for hylan g-f 20, sodium hyaluronate (batch number: unknown, expiration date: unknown) with global ptc number: (b)(4).The sample status was not available, and ptc stated the product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi will continue to monitor adverse events as stated in sop rdg-sop-000440 "product event handling"쳌 to determine if a capa is required.The final investigation was completed on 27-may-2021 with summarized conclusion as no assessment possible.Additional information received on 17-dec-2019 from consumer.Patient weight, race, ethnicity and height added.History of bilateral knee pain, chronic pneumonia, irritable bowel syndrome, breast mass removal, cervical discectomy, cesarean, gall bladder, hysterectomy, lt wrist/hand surgery, lung biopsy, sinus surgery, right knee surgery, left knee injury, back problems, allergies to carta xt, felodipine, morphine, nitroglycerin and valsartan, allergy to sulfa, no tobacco use and alcohol use.Concomitant medications included biotin, clonidine, montelukast sodium, omeprazole, pennsaid, ranolazine, spironolactone, symbicort, wixela and zyrtec.Suspect product indication updated.Clinical course updated.Text amended accordingly.Additional information received on 27-may-2021 from other health professional from quality department.Ptc results were added.
|
| |
|
Search Alerts/Recalls
|
|
