| Lot Number UNKNOWN |
| Device Problems
Off-Label Use (1494); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Pain (1994); Joint Disorder (2373); Weight Changes (2607); Test Result (2695); No Code Available (3191)
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Event Type
Injury
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Event Description
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This unsolicited case from (b)(6) was received on 27- sep-2017 from a patient.This case concerns an (b)(6) year old male patient who received treatment with synvisc one injection and later after unknown latencies experienced unspecified adverse event, left knee disorder nos (not otherwise specified), white blood cell analysis abnormal nos, weight loss (loss of 10kg) and 2 punctures at the level of knee and 6 bilateral injections of synvisc one within 3 weeks off label use.The patient received injection of adant viscoelastic products for 15 years.No relevant past drugs, concomitant medications and concurrent conditions were reported.On an unknown date in (b)(6) 2017, patients initiated treatment with intra- articular synvisc one 6 injections during 3 weeks (off label use) (frequency, indication and batch/lot: lj syr1 and expiration date: unknown).It was reported on an unspecified date (a tuesday), the patient received a synvisc one injection.On an unknown date (3 days later on friday), after unknown latency, the patient consulted emergency unit where he underwent resuscitation, 2 surgeries on 2 days and a loss of 10 kg.During the third week, the patient underwent 2 punctures of the left knee.Then the physician applied an unspecified product to dry knee skin.On an unknown date in (b)(6) 2017, after unknown latency, the patient's white blood cells analysis was abnormal.Action taken: unknown.Corrective treatment: surgeries and resuscitation for unspecified adverse event; 2 punctures at the level of the knee + unspecified product application for left knee disorder nos; not reported for rest of the events.Outcome: unknown for unspecified adverse event, left knee disorder nos, white blood cell analysis abnormal nos, weight loss (loss of 10kg) and 2 punctures at the level of knee.Seriousness criteria: hospitalization for unspecified adverse event (b)(6): c1s1b1 no further information was provided.Pharmacovigilance comment: sanofi company comment dated 03-oct-2017: this case concerns a male patient who received synvisc one injection and hospitalized with unspecified adverse events, left knee disorder and white blood cell analysis abnormal.Based upon the information available, the causal role of the product cannot be denied for the occurrence of event.However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection.Lack of further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors precludes the complete medical case assessment.
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Event Description
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This unsolicited case from (b)(6) was received on 27- sep-2017 from a patient.This case concerns an (b)(6) year old male patient who received treatment with 6 bilateral injections of synvisc one within 3 weeks/overdose (off label use) and after unknown latencies experienced unspecified adverse event, left knee disorder nos (not otherwise specified), white blood cell analysis abnormal nos, weight loss (loss of 10kg) and 2 punctures at the level of knee.Patient also had edema of the knee/edema of the thigh and pain after 16 days, walking difficulty and wound nos after unknown latency.The patient received injection of adant viscoelastic products for 15 years.No relevant past drugs, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patient initiated treatment with intra- articular synvisc one 6 bilateral injections during 3 weeks (off label use/overdose) (frequency, indication, lot number and expiration date: not reported).It was reported on an unspecified date (a tuesday), the patient received a synvisc one injection.On an unknown date (3 days later on friday), after unknown latency, the patient consulted emergency unit where he underwent resuscitation, 2 surgeries on 2 days and a loss of 10 kg.During the third week, the patient underwent 2 punctures of the left knee (onset date and latency: unknown).Then the physician applied an unspecified product to dry knee skin.On (b)(6) 2017, patient received the last synvisc one injection.During this timeframe 3 sessions of bilateral injections were performed and 6 ampoules of synvisc one were used.There was no information with regards to the volume injected at each session and the procedure used.On an unknown date in (b)(6) 2017, after unknown latency, after the second session of injections, white blood cells analysis was abnormal nos.Nevertheless, the physician performed the injections of the third session.Three days later, on (b)(6) 2017, the patient presented with edema of the knee and the thigh and pain (latency: 16 days).On an unknown date in (b)(6) 2017, after unknown latency, patient had walking difficulty and walked with crunches.He could not practice any longer tennis and motor biking.Patient lived in a house at the first floor and had difficulties do go down the stairs.The patient did not confirm the previously reported surgeries and loss of weight.Also reported that at the date of the contact a wound nos was closed only for 15 days (onset date and latency: unknown) and that pains, edema of the knee and walking with crunches persisted.At the date of the contact patient was not recovered.Corrective treatment: surgeries and resuscitation for unspecified adverse event; 2 punctures at the level of the knee + unspecified product application for left knee disorder nos; use of crunches for walking difficulty and not reported for white blood cell analysis abnormal nos, weight loss (loss of 10kg), edema of the knee/edema of the thigh, pain, 2 punctures at the level of knee, wound nos.Outcome: unknown for unspecified adverse event, left knee disorder nos, white blood cell analysis abnormal nos, weight loss (loss of 10kg) and 2 punctures at the level of knee; not recovered for edema of the knee/edema of the thigh, pain, walking difficulty, and recovered for wound nos a pharmaceutical technical complaint (ptc) was initiated with 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.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 criteria: hospitalization and life threatening for left knee disorder nos, white blood cell analysis abnormal nos, weight loss (loss of 10kg), 2 punctures at the level of knee, unspecified adverse event; hospitalization for edema of the knee/edema of the thigh, walking difficulty, pain and wound nos (b)(6) imputability: (b)(4) for edema of the knee/edema of the thigh, (b)(4) for walking difficulty and wound.Nos; c1s1b1 for other events.Additional information was received on 05-oct-2017.Global ptc number and ptc results were added.Clinical course was updated.Text was amended accordingly.Upon internal review on 05-oct-2017, batch/lot number was deleted.Life threatening was added as seriousness criterion for the events of left knee disorder nos, white blood cell analysis abnormal nos, weight loss (loss of 10kg), 2 punctures at the level of knee, unspecified adverse event.Additional information was received on 18-oct-2017 from patient.Patient's weight and height was added.Treatment start date of synvisc one was updated from (b)(6) 2017 to (b)(6) 2017 and treatment stop date was added.Additional events of pain, edema of the knee/edema of the thigh, walking difficulty and wound nos were added along with details.The event term 6 bilateral injections of synvisc one within 3 weeks /off label use was updated to 6 bilateral injections of synvisc one within 3 weeks overdose/off label use.Event onset of white blood cell analysis abnormal nos was updated from (b)(6) 2017 to (b)(6) 2017.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 21-oct-2017:this case concerns a male patient who received synvisc one injection and later had life threatening events of unspecified disorder of knee joint, white blood cell analysis abnormal, weight loss, and also hospitalized with edema of lower limbs, pain, walking difficulty and wound nos.Based upon the information available, the causal role of the product cannot be denied for the occurrence of events.However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection.Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors precludes the complete medical case assessment.
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Event Description
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This unsolicited case from france was received on (b)(6) 2017 from a patient.This case concerns an (b)(6) male patient who received treatment with synvisc one injection and later after unknown latencies experienced unspecified adverse event, left knee disorder nos (not otherwise specified), white blood cell analysis abnormal nos, weight loss (loss of 10kg) and 2 punctures at the level of knee and 6 bilateral injections of synvisc one within 3 weeks off label use.The patient received injection of adant viscoelastic products for 15 years.No relevant past drugs, concomitant medications and concurrent conditions were reported.On an unknown date in (b)(6) 2017, patients initiated treatment with intra- articular synvisc one 6 injections during 3 weeks (off label use) (frequency, indication and batch/lot and expiration date: not reported).It was reported on an unspecified date (a tuesday), the patient received a synvisc one injection.On an unknown date (3 days later on friday), after unknown latency, the patient consulted emergency unit where he underwent resuscitation, 2 surgeries on 2 days and a loss of 10 kg.During the third week, the patient underwent 2 punctures of the left knee.Then the physician applied an unspecified product to dry knee skin.On an unknown date in (b)(6) 2017, after unknown latency, the patient's white blood cells analysis was abnormal.Action taken: unknown.Corrective treatment: surgeries and resuscitation for unspecified adverse event; 2 punctures at the level of the knee + unspecified product application for left knee disorder nos; not reported for rest of the events.Outcome: unknown for unspecified adverse event, left knee disorder nos, white blood cell analysis abnormal nos, weight loss (loss of 10kg) and 2 punctures at the level of knee.A pharmaceutical technical complaint (ptc) was initiated with 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.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 criteria: hospitalization and life threatening for left knee disorder nos, white blood cell analysis abnormal nos, weight loss (loss of 10kg), 2 punctures at the level of knee, unspecified adverse event.French imputability: c1s1b1 for all events.No further information was provided.Additional information was received on 05-oct-2017.Global ptc number and ptc results were added.Clinical course was updated.Text was amended accordingly.Upon internal review on 05-oct-2017, batch/lot number was deleted.Life threatening was added as seriousness criterion for the events of left knee disorder nos, white blood cell analysis abnormal nos, weight loss (loss of 10kg), 2 punctures at the level of knee, unspecified adverse event.Pharmacovigilance comment: sanofi company comment follow up dated 05-oct-2017: this case concerns a male patient who received synvisc one injection and later had life threatening events of unspecified disorder of knee joint, white blood cell analysis abnormal, and weight loss for which patient remain hospitalized.Based upon the information available, the causal role of the product cannot be denied for the occurrence of events.However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection.Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors precludes the complete medical case assessment.
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Event Description
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Based on additional information received on 08-nov- 2017, the case needs to be deleted since the patient did not receive synvisc or synvisc one.This unsolicited case from (b)(6) was received on (b)(6) 2017 from a patient.This case concerns an (b)(6) male patient who received treatment with 6 bilateral injections of synvisc one within 3 weeks/overdose (off label use) and after unknown latencies experienced unspecified adverse event, left knee disorder nos (not otherwise specified), white blood cell analysis abnormal nos, weight loss (loss of 10kg) and 2 punctures at the level of knee.Patient also had edema of the knee/edema of the thigh and pain after 16 days, walking difficulty and wound nos after unknown latency.The patient received injection of adant viscoelastic products for 15 years.No relevant past drugs, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patient initiated treatment with intra- articular synvisc one 6 bilateral injections during 3 weeks (off label use/overdose) (frequency, indication, lot number and expiration date: not reported).It was reported on an unspecified date (a tuesday), the patient received a synvisc one injection.On an unknown date (3 days later on friday), after unknown latency, the patient consulted emergency unit where he underwent resuscitation, 2 surgeries on 2 days and a loss of 10 kg.During the third week, the patient underwent 2 punctures of the left knee (onset date and latency: unknown).Then the physician applied an unspecified product to dry knee skin.On (b)(6) 2017, patient received the last synvisc one injection.During this timeframe 3 sessions of bilateral injections were performed and 6 ampoules of synvisc one were used.There was no information with regards to the volume injected at each session and the procedure used.On an unknown date in (b)(6) 2017, after unknown latency, after the second session of injections, white blood cells analysis was abnormal nos.Nevertheless, the physician performed the injections of the third session.Three days later, on (b)(6) 2017, the patient presented with edema of the knee and the thigh and pain (latency: 16 days).On an unknown date in (b)(6) 2017, after unknown latency, patient had walking difficulty and walked with crunches.He could not practice any longer tennis and motor biking.Patient lived in a house at the first floor and had difficulties do go down the stairs.The patient did not confirm the previously reported surgeries and loss of weight.Also reported that at the date of the contact a wound nos was closed only for 15 days (onset date and latency: unknown) and that pains, edema of the knee and walking with crunches persisted.At the date of the contact patient was not recovered.Physician clarified that the patient did not receive injections of synvisc nor synvisc one at all.The patient had received hyaluronic acid (go-on).Reporter stated that events reported by the patient were not due to hyaluronic acid injections.There was a notion of hygroma pre-patellar before the patient went to a cruise.Corrective treatment: surgeries and resuscitation for unspecified adverse event; 2 punctures at the level of the knee + unspecified product application for left knee disorder nos; use of crunches for walking difficulty and not reported for white blood cell analysis abnormal nos, weight loss (loss of 10kg), edema of the knee/edema of the thigh, pain, 2 punctures at the level of knee, wound nos.Outcome: unknown for unspecified adverse event, left knee disorder nos, white blood cell analysis abnormal nos, weight loss (loss of 10kg) and 2 punctures at the level of knee; not recovered for edema of the knee/edema of the thigh, pain, walking difficulty, and recovered for wound nos.A pharmaceutical technical complaint (ptc) was initiated with 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.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 criteria: hospitalization and life threatening for left knee disorder nos, white blood cell analysis abnormal nos, weight loss (loss of 10kg), 2 punctures at the level of knee, unspecified adverse event; hospitalization for edema of the knee/edema of the thigh, walking difficulty, pain and wound nos.(b)(6) imputability: c1s2b3 for edema of the knee/edema of the thigh, c1s2b1 for walking difficulty and wound nos; c1s1b1 for other events.Additional information was received on 05-oct-2017.Global ptc number and ptc results were added.Clinical course was updated.Text was amended accordingly.Upon internal review on 05-oct-2017, batch/lot number was deleted.Life threatening was added as seriousness criterion for the events of left knee disorder nos, white blood cell analysis abnormal nos, weight loss (loss of 10kg), 2 punctures at the level of knee, unspecified adverse event.Additional information was received on 18-oct-2017 from patient.Patient's weight and height was added.Treatment start date of synvisc one was updated from (b)(6) 2017 to (b)(6) 2017 and treatment stop date was added.Additional events of pain, edema of the knee/edema of the thigh, walking difficulty and wound nos were added along with details.The event term 6 bilateral injections of synvisc one within 3 weeks /off label use was updated to 6 bilateral injections of synvisc one within 3 weeks overdose/off label use.Event onset of white blood cell analysis abnormal nos was updated from (b)(6) 2017 to (b)(6) 2017.Clinical course was updated and text was amended accordingly.Follow up information was received on 17-oct-2017.No new information was received.Additional information was received on 08-nov-2017 from the physician (specialist in physical medicine and in rehabilitation).The case needs to be deleted since the patient did not receive synvisc or synvisc one and the reported events were not due to the company suspect product.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 08-nov-2017: as per follow up information, the patient was not receiving synvisc one injection and was on hyaluronic acid (go-on) after which life threatening events of unspecified disorder of knee joint, white blood cell analysis abnormal, weight loss, and also hospitalized with edema of lower limbs, pain, walking difficulty and wound nos occured.Based upon the information available, the causal role with the product cannot be established.
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