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

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/22/2020

Event Type  Injury  

Event Description

Covid 19 [covid-19].Synvisc medication is ineffective [device ineffective].Case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from patient via health authorities (mw5098329) from united states.This case involves an adult male patient who experienced covid 19 and synvisc medication was ineffective, while he was using the 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.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate (formulation, strength, dose, frequency, route, batch number: unknown) for unilateral primary osteoarthritis right knee.There will be no information available for batch number of this case.On (b)(6) 2020, after unknown latency, patient was diagnosed with covid-19 due to which he was hospitalized in 2020.On an unknown date in 2020, patient was discharged.It was reported that his hylan g-f 20, sodium hyaluronate medication was ineffective (device ineffective; onset date and latency: unknown) so his doctor would be prescribing him a new therapy.Final diagnosis was covid 19 and synvisc medication is ineffective.Action taken: not applicable for device ineffective and unknown for covid-19.It was not reported if the patient received a corrective treatment for both events outcome: unknown for covid 19 and not applicable for synvisc medication is ineffective.Seriousness criteria: hospitalization.A product technical complaint (ptc) was initiated on 04-feb-2021 for synvisc.Batch number: unknown; comet compliant id 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 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.Final investigation complete date was 10-feb-2021.No safety issues were indicated in this review.Additional information was received on 10-feb-2021 from the other healthcare professional.Global ptc number and ptc results were added.Clinical course updated and text amended accordingly.

Event Description

Covid 19 [covid-19].Synvisc medication is ineffective [device ineffective].Case narrative: initial information received on 04-feb-2021 regarding an unsolicited valid serious case received from patient via health authorities (mw5098329) from united states.This case involves an adult male patient who experienced covid 19 and synvisc medication was ineffective, while he was using the 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.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate (formulation, strength, dose, frequency, route, batch number: unknown) for unilateral primary osteoarthritis right knee.There will be no information available for batch number of this case.On 22-apr-2020, after unknown latency, patient was diagnosed with covid-19 due to which he was hospitalized in 2020.On an unknown date in 2020, patient was discharged.It was reported that his hylan g-f 20, sodium hyaluronate medication was ineffective (device ineffective; onset date and latency: unknown) so his doctor would be prescribing him a new therapy.Final diagnosis was covid 19 and synvisc medication is ineffective.Action taken: not applicable for device ineffective and unknown for covid-19.It was not reported if the patient received a corrective treatment for both events.Outcome: unknown for covid 19 and not applicable for synvisc medication is ineffective.Seriousness criteria: hospitalization.A product technical complaint (ptc) was initiated on 04-feb-2021 for synvisc.Batch number: unknown; comet compliant id 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 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.Final investigation complete date was 10-feb-2021.No safety issues were indicated in this review.Additional information was received on 10-feb-2021 from the other healthcare professional.Global ptc number and ptc results were added.Clinical course updated and text amended accordingly.Follow up information was received on 24-mar-2021 from the other healthcare professional.Investigation with (b)(4) was reopened due to incomplete compliant information.No significant added.Upon internal review on 10-feb-2021 the incident characterization was updated from other to reportable side effect for the suspect product.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11336724
• MDR Text Key: 240794616
• Report Number: 2246315-2021-00070
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention