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

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

Patient Problems Arthritis (1723); Bacterial Infection (1735); Cellulitis (1768); Hypersensitivity/Allergic reaction (1907)

Event Date 10/01/2015

Event Type  Injury  

Event Description

Cellulitis [cellulitis].Septic arthritis [septic arthritis].Allergic reaction to synvisc [allergic reaction].Case narrative: initial information was received on 08-dec-2020 regarding a solicited valid serious case from a physician, in the scope of market research program (b)(4).(b)(6).This case involves a (b)(6) years old female patient who experienced cellulitis, septic arthritis and allergic reaction to synvisc, after with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.On an unknown date, the patient started using synvisc (hylan g-f 20, sodium hyaluronate) (with an unknown batch number, dose, frequency, route and indication).Information on batch number was requested.On an unknown date in (b)(6) 2015, after unknown latency, the patient experienced moderate septic arthritis (arthritis bacterial), moderate cellulitis and moderate allergic reaction to synvisc (hypersensitivity).The patient was hospitalized for all the reported events.The events of cellulitis and septic arthritis were assessed as medically significant.The patient received unspecified antibiotics as corrective treatment for the events.Final diagnosis was allergic reaction to synvisc, septic arthritis and cellulitis.Action taken: unknown for all the events.Corrective treatment: unspecified antibiotics for all the events.The patient outcome is reported as unknown for all the events.Reporter causality: unassessable for all the events.Company causality: reportable for all the events.A product technical complaint (ptc) was initiated, and results were pending for the same.

Event Description

Cellulitis [cellulitis].Septic arthritis [septic arthritis].Allergic reaction to synvisc [allergic reaction].Case narrative: initial information was received on 08-dec-2020 regarding a solicited valid serious case from a physician, in the scope of market research program "mrs_20-2318".Patient id: (b)(6); country: mexico.Study title: ostheo psp evaluation.This case involves a 32 years old female patient who experienced cellulitis, septic arthritis and allergic reaction to synvisc, after with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.On an unknown date, the patient started using synvisc (hylan g-f 20, sodium hyaluronate) (strength: 16mg/2ml) (with an unknown batch number, dose, frequency, route, indication and expiry date).Information on batch number was requested.On an unknown date in (b)(6) 2015, after unknown latency, the patient experienced moderate septic arthritis (arthritis bacterial), moderate cellulitis and moderate allergic reaction to synvisc (hypersensitivity).The patient was hospitalized for all the reported events.The events of cellulitis and septic arthritis were assessed as medically significant.The patient received unspecified antibiotics as corrective treatment for the events.Action taken: unknown for all the events.Corrective treatment: unspecified antibiotics for all the events.The patient outcome is reported as unknown for all the events.Reporter causality: unassessable for all the events.Company causality: reportable for all the events.A product technical complaint (ptc) was initiated on 08-dec-2020 for synvisc (hylan g-f 20, sodium hyaluronate) (batch number: unknown) with global ptc number: (b)(4).The sample was not available and ptc stated: 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 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 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.The final investigation was completed on 09-mar-2021 with summarized conclusion as no assessment possible.Additional information was received on 09-mar-2021 from quality department: ptc details with summarized conclusion and suspect strength added.Text was amended accordingly.

• 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: 11018524
• MDR Text Key: 226771419
• Report Number: 2246315-2020-00169
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 32 YR
• Patient Sex: Female