MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC; MOZ

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 28-mar-2024: this case involves an approximately 66 year old female patient who had pain in her toe and inflammation, while being treated with device hylan g-f 20, sodium hyaluronate [synvisc].Based on the limited available information, the causal role of the company suspect drug could not be denied for the occurrence of adverse event, however the device was administered at inappropriate site which could be the cofounding reason.

Event Description

Pain in her toe and inflammation [pain in toe].Pain in her toe and inflammation [inflammation localised].She did not remember how much she received as far as the dosage but that it did not make a difference with no reported adverse event [device ineffective].Had a synvisc injection in the left toe for osteoarthritis with no reported adverse event [product administered at inappropriate site].Case narrative: initial information was received on 26-mar-2024 regarding an unsolicited valid serious case received from other health professional.This case involves "an approximately" 66 year old female patient who had pain in her toe and inflammation, while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc].She did not remember how much she received as far as the dosage but that it did not make a difference and had a synvisc injection in the left toe for osteoarthritis with no adverse event reported.The patient's past medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.It is unknown if the patient had any medical history, concomitant disease or risk factor.In 2022, about a year and a half ago, the patient started using hylan g-f 20, sodium hyaluronate injection (strength: 16mg/2ml, with an unknown dose, route and frequency) in left toe for osteoarthritis (product administered at inappropriate site) (same day latency).Patient mentioned on the synvisc patient support line that she had a synvisc injection in the left toe about a year and a half ago for osteoarthritis.She did not remember how much she received as far as the dosage but that it did not make a difference (device ineffective) (unknown latency) (unknown batch number and expiry date).The patient said that she had received cortisone and that there was much less pain in her toe and inflammation (pain in extremity) (inflammation) (unknown latency) (unknown batch number and expiry date).She received the cortisone prior to the synvisc and after.Patient was considering receiving synvisc in her knee.Information on batch number and expiry date was requested.It was unknown if there were lab data/results available.Action taken: unknown for pain in extremity and inflammation.The patient was treated with cortisone for pain in extremity and inflammation.At time of reporting, the outcome was not recovered for pain in extremity and inflammation.Seriousness criteria: intervention required for pain in extremity and inflammation.

Event Description

Pain in her toe and inflammation [pain in toe].Pain in her toe and inflammation [inflammation localised].She did not remember how much she received as far as the dosage but that it did not make a difference/it didn't help with the pain with no reported adverse event [device ineffective].Had a synvisc injection in the left toe for osteoarthritis with no reported adverse event [product administered at inappropriate site].Case narrative: initial information was received on 26-mar-2024 regarding an unsolicited valid serious case received from other health professional.This case involves "an approximately" 66 year old female patient who had pain in her toe and inflammation, while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc].She did not remember how much she received as far as the dosage but that it did not make a difference/it didn't help with the pain and had a synvisc injection in the left toe for osteoarthritis with no adverse event reported directly linked to this product administered at inappropriate site and device ineffective.The patient's past medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.It is unknown if the patient had any medical history, concomitant disease or risk factor.In 2022, about a year and a half ago, the patient started using hylan g-f 20, sodium hyaluronate injection, liquid (solution) (strength: 16mg/2ml, with an unknown dose, route and frequency) in left toe for osteoarthritis (product administered at inappropriate site) (same day latency)(unknown batch number and expiry date).Patient mentioned on the synvisc patient support line that she had a synvisc injection in the left toe about a year and a half ago for osteoarthritis.She did not remember how much she received as far as the dosage but that it did not make a difference and it didn't help with the pain (device ineffective) (unknown latency) (unknown batch number and expiry date).The patient said that she had received cortisone and that there was much less pain in her toe and inflammation (pain in extremity) (inflammation) (unknown latency) (unknown batch number and expiry date).She received the cortisone prior to the synvisc and after.Patient was considering receiving synvisc in her knee.Information on batch number and expiry date was requested.It was unknown if there were lab data/results available.Action taken: unknown for pain in extremity and inflammation.The patient was treated with cortisone for pain in extremity and inflammation.At time of reporting, the outcome was not recovered for pain in extremity and inflammation.Seriousness criteria: intervention required for pain in extremity and inflammation.A product technical complaint (ptc) was initiated on 26-mar-2024 for synvisc (lot/batch number: unknown) with global ptc number: 100412924.The sample of the ptc was not available and the ptc stated: preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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.The defect class has been updated to ii.(rc 28mar24) investigation: (rc 28mar24) the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.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 nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive actions) is required.The final investigation was completed on 28-mar-2024 with summarized conclusion as no assessment possible.Additional information was received on 28-mar-2024 from quality department via other healthcare professional: ptc number, details and results were added.As reported term for event device ineffective was updated and text was amended.

Event Description

Had a synvisc injection in the left toe for osteoarthritis with no reported adverse event [product administered at inappropriate site] it did not make a difference/it didn't help with the pain with no adverse event [device ineffective].Case narrative: initial information received on 26-mar-2024 regarding a solicited valid case received from a other health professional, in the scope of post-marketing sponsored study "spon_i_synvisc", case was downgraded to non-serious on 26-mar-2024.Study title: patient support program involving synvisc.This case involves 66 year old female patient who had a synvisc injection in the left toe for osteoarthritis, it did not make a difference/it didn't help with the pain with no adverse event reported while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing pain in extremity and inflammation.Concomitant medications included cortisone for osteoarthritis.In 2022, about a year and a half ago, the patient started using synvisc (hylan g-f 20, sodium hyaluronate) injection, liquid (solution) (strength: 16mg/2ml, with an unknown dose, route and frequency) in left toe for osteoarthritis (product administered at inappropriate site) (same day latency)(unknown batch number and expiry date).On an unknown date the patient developed a non-serious event "it did not make a difference/it didn't help with the pain with no adverse event" (device ineffective) (unknown latency) (unknown batch number and expiry date)after starting use of hylan g-f 20 and sodium hyaluronate information on batch number and expiry date was requested.It was reported "patient mentioned on the synvisc patient support line that she had a synvisc injection in the left toe about a year and a half ago for osteoarthritis.She did not remember how much she received as far as the dosage but that it did not make a difference and it didn't help with the pain.The patient said that she had received cortisone and that there was much less pain in her toe and inflammation.She received the cortisone prior to the synvisc and after.Patient was considering receiving synvisc in her knee.Patient further inquire about synvisc.She reported: " her doctor suggested this product, but she was wondering what the chances are that it will work for her knee if it didn't work for her toe." she asked what's the difference between synvisc and synvisc-one.On what basis does the doctor choose one or the other and what is the possible duration of effect for this product.It was unknown if there were lab data/results available.".A product technical complaint (ptc) was initiated on 26-mar-2024 for synvisc (lot/batch number: unknown) with global ptc number: (b)(4).The sample of the ptc was not available and the ptc stated: preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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.The defect class has been updated to ii.(rc 28mar24) investigation: (rc 28mar24) the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.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 nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive actions) is required.The final investigation was completed on 28-mar-2024 with summarized conclusion as no assessment possible.Additional information was received on 28-mar-2024 from quality department via other healthcare professional: ptc number, details and results were added.As reported term for event device ineffective was updated and text was amended.Additional information was received on 26-mar-2024 from patient: case has been updated from unsolicited non literature to solicited other.Also, based on previously received information, the case initially considered as serious was downgraded to non-serious; treatment drug cortisone was updated to concomitant; serious event of pain in extremity, inflammation were deleted and were made as concurrent condition; clinical course was updated and text was amended accordingly.Local comments: *downgrade*.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 18997134
• MDR Text Key: 338890921
• Report Number: 2246315-2024-00021
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CORTISONE (CORTISONE),UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Sex: Female