| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Hypersensitivity/Allergic reaction (1907); No Code Available (3191)
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| Event Date 01/13/2020 |
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Event Type
Injury
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Event Description
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Allergic reaction [allergic reaction] ([swelling nos], [erythema nos], [pain nos], [effusion]).Case narrative: initial information received on 22-jan-2020 from united states regarding an unsolicited valid serious case received from a nurse via sales representative.This case involves a (b)(6) years old female patient who experienced an allergic reaction, with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.On an unknown date in (b)(6) 2020, the patient started treatment with three series injection of hylan g-f 20, sodium hyaluronate and had received the first injection via intra-articular route (dose, frequency, indication, batch: unknown) (information for batch number was requested).On an unknown date in (b)(6) 2020, after the injection, patient experienced redness, swelling and pain.The pain was so intense that the patient had to visit the emergency room and fluid was aspirated.The physician assistant listed the events as an allergic reaction (latency: unknown) (onset: (b)(6) 2020) in her chart.This event was assessed as serious and was medically significant.Action taken: unknown.Corrective treatment: fluid was aspirated.Outcome: unknown.A product technical complaint was initiated and results were pending for the same.
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Manufacturer Narrative
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Sanofi company comment 10-feb-2020.This case concerns a patient who received treatment with synvisc and later experienced an allergic reaction right knee pain and effusion for which she had to visit the emergency room and undergo fluid aspiration.Based on information provided, causal role of suspect product cannot be excluded.However, more information regarding patient's concurrent clinical presentation and other risk factors is required for further case assessment.
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Event Description
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Allergic reaction [allergic reaction] ([joint inflammation], [stiff knees], [swelling of r knee], [erythema nos], [aching (r) knee], [joint effusion]).Range of motion is limited [joint range of motion decreased].Hurts with weightbearing [weight bearing difficulty].Case narrative: this case is cross-referenced with (b)(4) (same patient, multiple devices).Initial information received on 22-jan-2020 from united states regarding an unsolicited valid serious case received from a nurse via sales representative.This case involves a 49 years old female patient who experienced an allergic reaction (latency: 1 day), hurts with weightbearing (latency: unknown), range of motion is limited (latency: unknown) with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's medical treatment(s), vaccination(s) and family history were not provided.The patient's past medical history included bipolar disorder, cervical cancer, urge incontinence, cervix cone biopsy, colonoscopy diagnostic on (b)(6) 2014 with again on (b)(6) 2018, foot / ankle surgery right, hysterectomy, laparoscopic cholecystectomy, laparoscop rep umblical hernia, upper gi endoscopy on (b)(6) 2013 with again on (b)(6) 2014, upper gi endoscopy, former smoker and no alcohol use.The family history included hypertension, asthma to biological mother and hypertension, coronary artery disease, copd to biological father.At the time of the event, the patient had ongoing abstains from alcohol, drug hypersensitivity with reaction: itchiness and arthralgia.Concomitant medications included albuterol sulfate for shortness of breath; aripiprazole (abilify); fluticasone furoate, vilanterol trifenatate (breo ellipta); cetirizine hydrochloride (zyrtec); lamotrigine (lamictal); meloxicam (mobic); mirabegron (myrbetriq); omeprazole (prilosec); salbutamol (ventoline) for shortness of breath; and vitamin d.On (b)(6) 2019, the patient started treatment with three series injection of hylan g-f 20, sodium hyaluronate and had received the first injection via intra-articular route in right knee of 2 ml each (frequency, batch: unknown) (information for batch number was requested) for osteoarthrosis, localized, primary, involving lower leg, right.On (b)(6)2020, the patient received second injection, after the injection, patient experienced redness, swelling and pain.The patient had significant amount of swelling.The patient complained of stiffness as well she denied fever or chills.The pain was so intense that the patient had to visit the emergency room and fluid was aspirated.On (b)(6) 2020, the patient had effusion of right knee and arthrocentesis right knee was carried out.On the visit, the patient had a large effusion without erythema or warmth however range of motion was limited due to this effusion.The physician assistant listed the events as an allergic reaction (latency: unknown) (onset: on (b)(6) 2020) in her chart.This event was assessed as serious and was medically significant.It was reported that there was pseudo-flare allergic reaction.There was no active infection.On (b)(6) 2020, there was arthrocentesis / injection procedure for right knee and 38 ml of straw colored fluid was removed and sent.5 ml of marcaine 0.5% and 40 mg of methylprednisolone was injected for effusion of right knee joint (intervention required).There was still some knee pain and gram stain cultures were negative and the range of motion 0 to 110 degrees strength was limited by this effusion.The patient was currently not doing physical therapy.On the visit on (b)(6) 2020, patient complained of right knee pain that continued over the medial aspect of her knee she did have this aspirated after a pseudo-flare from synvisc corticosteroid also given, the patient was doing better but not perfect, it hurts with weightbearing.It was reported that the right knee that day was without effusion which was good range of motion 0 to 120 degrees no varus valgus instability, and still significantly tender over the medial tibial plateau.Action taken: unknown for all events.Corrective treatment: fluid was aspirated for allergic reaction and all symptoms, 0.5% marcaine, methylprednisolone for joint effusion ;fluid was aspirated,tylenol for pain, but states it is not helping, ice, icy hot, advil for arthralgia, fluid was aspirated,ice, icy hot, advil for pain for right knee swelling.Outcome: unknown for all events.A product technical complaint was initiated with global ptc number: 100018277 and results were pending for the same.Follow up information was received on 23-jan-2020 from other healthcare professional.Global ptc number added.No significant information was received.Additional information was received on 10-feb-2020 from a healthcare professional.Suspect therapy regimen updated.Events added for hurts with weightbearing, range of motion is limited.Symptoms of allergic reaction added as right knee stiffness / get a little tight, pseudo-flare allergic reaction.Medical history and concomitant medications added.Verbatim updated for symptoms.Clinical course was updated.Text amended accordingly.
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Manufacturer Narrative
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Sanofi company comment 10-feb-2020.This case concerns a patient who received treatment with synvisc and later experienced an allergic reaction right knee pain and effusion for which she had to visit the emergency room and undergo fluid aspiration.Based on information provided, causal role of suspect product cannot be excluded.However, more information regarding patient's concurrent clinical presentation and other risk factors is required for further case assessment.
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Event Description
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Allergic reaction [allergic reaction] ([joint inflammation], [stiff knees], [swelling of r knee], [erythema nos], [aching (r) knee], [joint effusion]) range of motion is limited [joint range of motion decreased] hurts with weightbearing [weight bearing difficulty].Case narrative: this case is cross-referenced with (b)(4) (same patient, multiple devices).Initial information received on 22-jan-2020 from united states regarding an unsolicited valid serious case received from a nurse via sales representative.This case involves a 49 years old female patient who experienced an allergic reaction (latency: 1 day), hurts with weightbearing (latency: unknown), range of motion is limited (latency: unknown) with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's medical treatment(s), vaccination(s) and family history were not provided.The patient's past medical history included bipolar disorder, cervical cancer, urge incontinence, cervix cone biopsy, foot/ankle surgery right, hysterectomy, laparoscopic cholecystectomy, laparoscop rep umblical hernia, upper gi endoscopy on (b)(6) 2013 with again on (b)(6) 2014, colonoscopy diagnostic on (b)(6) 2014 with again on (b)(6) 2018, upper gi endoscopy, former smoker and no alcohol use.The family history included hypertension, asthma to biological mother and hypertension, coronary artery disease, copd to biological father.At the time of the event, the patient had ongoing abstains from alcohol, drug hypersensitivity with reaction: itchiness and arthralgia.Concomitant medications included albuterol sulfate for shortness of breath; aripiprazole (abilify); fluticasone furoate, vilanterol trifenatate (breo ellipta); cetirizine hydrochloride (zyrtec); lamotrigine (lamictal); meloxicam (mobic); mirabegron (myrbetriq); omeprazole (prilosec); salbutamol (ventoline) for shortness of breath; and vitamin d.On (b)(6) 2019, the patient started treatment with three series injection of hylan g-f 20, sodium hyaluronate and had received the first injection via intra-articular route in right knee of 2 ml each (frequency, batch: unknown) (information for batch number was requested) for osteoarthrosis, localized, primary, involving lower leg, right.On (b)(6) 2020, the patient received second injection, after the injection, patient experienced redness, swelling and pain.The patient had significant amount of swelling.The patient complained of stiffness as well she denied fever or chills.The pain was so intense that the patient had to visit the emergency room and fluid was aspirated.On (b)(6) 2020, the patient had effusion of right knee and arthrocentesis right knee was carried out.On the visit, the patient had a large effusion without erythema or warmth however range of motion was limited due to this effusion.The physician assistant listed the events as an allergic reaction (latency: unknown) (onset: (b)(6) 2020) in her chart.This event was assessed as serious and was medically significant.It was reported that there was pseudo-flare allergic reaction.There was no active infection.On (b)(6) 2020, there was arthrocentesis/lnjection procedure for right knee and 38 ml of straw colored fluid was removed and sent.5 ml of marcaine 0.5% and 40 mg of methylprednisolone was injected for effusion of right knee joint (intervention required).There was still some knee pain and gram stain cultures were negative and the range of motion 0 to 110degrees strength was limited by this effusion.The patient was currently not doing physical therapy.On the visit of (b)(6) 2020, patient complained of right knee pain that continued over the medial aspect of her knee she did have this aspirated after a pseudo-flare from synvisc corticosteroid also given, the patient was doing better but not perfect, it hurts with weightbearing.It was reported that the right knee that day was without effusion which was good range of motion 0 to 120 degrees no varus valgus instability, and still significantly tender over the medial tibial plateau.Action taken: unknown for all events.Corrective treatment: fluid was aspirated for allergic reaction and all symptoms, 0.5% marcaine, methylprednisolone for joint effusion ;fluid was aspirated,tylenol for pain, but states it is not helping, ice, icy hot, advil for arthralgia, fluid was aspirated,ice, icy hot, advil for pain for right knee swelling.Outcome: unknown for all events.A product technical complaint (ptc) was initiated on (b)(6) 2020 for synvisc with unknown batch number and global ptc number: 100018277.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 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 would continue to monitor adverse events to determine if a capa was required.Investigation complete date: 14-apr-2020.Follow up information was received on 23-jan-2020 from other healthcare professional.Global ptc number added.No significant information was received.Additional information was received on 10-feb-2020 from a healthcare professional.Suspect therapy regimen updated.Events added for hurts with weightbearing, range of motion is limited.Symptoms of allergic reaction added as right knee stiffness/get a little tight, pseudo-flare allergic reaction.Medical history and concomitant medications added.Verbatim updated for symptoms.Clinical course was updated.Text amended accordingly.Additional information was received on 14-apr-2020 from healthcare professional.Investigation summary results were added.Text amended accordingly.
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