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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ
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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
Hospitalized for unknown reasons [hospitalization].Her knee flared up [unspecified disorder of knee joint] ([clinical flare reaction]).Case narrative: initial information received on 17-aug-2021 (previously a non case) and 16-sep-2021 regarding an unsolicited valid serious case received from a other health professional.This case involves an unknown age female patient who was hospitalized for unknown reasons and her knee flared up while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection (dosage, route, frequency, batch number unknown) for unknown indication.The information regarding lot number was requested.Reportedly, the medication worked great.On an unknown date, after unknown latency, the patient was hospitalized for unknown reasons (hospitalization and seriousness criteria: hospitalization) and her knee flared up (arthropathy, condition aggravated) and the patient would like another injection.Action taken: not applicable.It was not reported if the patient received a corrective treatment for the events (hospitalized for unknown reasons, her knee flared up, clinical flare reaction).At time of reporting, the outcome was unknown for the event hospitalized for unknown reasons and was unknown for the event her knee flared up.
 
Event Description
Hospitalized for unknown reasons [hospitalization].Her knee flared up [unspecified disorder of knee joint] ([condition aggravated]).Case narrative: initial information received on (b)(6) 2021 (previously a non case) and (b)(6)2021 regarding an unsolicited valid serious case received from a other health professional.This case involves an unknown age female patient who was hospitalized for unknown reasons and her knee flared up while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48 mg / 6 ml) (dosage, route, frequency, batch number unknown) for unknown indication.The information regarding lot number was requested.Reportedly, the medication worked great.On an unknown date, after unknown latency, the patient was hospitalized for unknown reasons (hospitalization and seriousness criteria: hospitalization) and her knee flared up (arthropathy, condition aggravated) and the patient would like another injection.Action taken: not applicable.It was not reported if the patient received a corrective treatment for the events (hospitalized for unknown reasons, her knee flared up, clinical flare reaction).At time of reporting, the outcome was unknown for the event hospitalized for unknown reasons and was unknown for the event her knee flared up.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on (b)(6) 2021 for product synvisc one.Batch number; unknown; sample status: not available the investigation was in process.Additional information was received on 17-sep-2021 from healthcare professional.Global ptc number, formulation, and strength were added.Text was amended accordingly.
 
Event Description
Hospitalized for unknown reasons [hospitalization].Her knee flared up [unspecified disorder of knee joint] ([condition aggravated]).Case narrative: initial information received on (b)(6) 2021 (previously a non case) and (b)(6) 2021 regarding an unsolicited valid serious case received from a other health professional.This case involves an unknown age female patient who was hospitalized for unknown reasons and her knee flared up while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48 mg / 6 ml) (dosage, route, frequency, batch number unknown) for unknown indication.The information regarding lot number was requested.Reportedly, the medication worked great.On an unknown date, after unknown latency, the patient was hospitalized for unknown reasons (hospitalization and seriousness criteria: hospitalization) and her knee flared up (arthropathy, condition aggravated) and the patient would like another injection.Action taken: not applicable.It was not reported if the patient received a corrective treatment for the events (hospitalized for unknown reasons, her knee flared up, clinical flare reaction).At time of reporting, the outcome was unknown for the event hospitalized for unknown reasons and was unknown for the event her knee flared up.A product technical complaint (ptc) was initiated with global ptc number (b)(4)on (b)(6) -2021 for product synvisc one.Batch number; unknown; sample status: not available the product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa (corrective and preventive action) is 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 (nonconformance report) 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 complaints to determine if a capa was required.Final investigation was completed on (b)(6) 2021 and conclusion summarized as no assessment possible.Additional information was received on 17-sep-2021 from healthcare professional.Global ptc number, formulation, and strength were added.Text was amended accordingly.Additional information was received on 29-sep-2021 from other healthcare professional.Ptc results received and processed.Text amended accordingly.
 
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Brand Name
SYNVISC ONE
Type of Device
MOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
MDR Report Key12530505
MDR Text Key276369169
Report Number2246315-2021-00157
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
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 Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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