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

Lot Number UNKNOWN

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

Patient Problems Erythema (1840); Joint Swelling (2356)

Event Date 10/05/2017

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment for follow up dated 21-jan-2021: follow up information does not change the prior case assessment.This case concerns a patient who was on treatment with synvisc and reported to have serious injury: redness, swelling of knee with no rash or itching.The information in the case is very limited, therefore, the causality with the device cannot be established.Further, detailed information regarding medical history, clinical course of event, therapy details would aid in comprehensive assessment of the case.

Event Description

Redness, swelling (knee), no rash or itching [localized erythema].Redness, swelling (knee), no rash or itching [knee swelling].Case narrative: initial information received on 08-jan-2021 regarding an unsolicited valid serious case received from pharmacist via health authorities of united states under reference mw5097698.This case involves adult patient who experienced redness, swelling (knee), no rash or itching with the use of medical device 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 using hylan g-f 20, sodium hyaluronate (strength: 8mg/ml) intra-articular injection (dose, frequency, lot, indication: unknown).Information on the batch number was requested.On (b)(6) 2017, after unknown latency, patient had redness, swelling (knee), no rash or itching (erythema, joint swelling) which lasted for about a week.Events assessed as medically significant due to serious injury.Action taken: not applicable for both events.It was not reported if the patient received a corrective treatment.Outcome: recovered for both events.A product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc one.Batch number: unknown; global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformances 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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa is required.Investigation complete date: 21-jan-2021.Follow-up was received on 08-jan-2021 from other healthcare professional.Global ptc number.No significant information received.Additional information was received on 21-jan-2021 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.Text amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 11235480
• MDR Text Key: 233147920
• Report Number: 2246315-2021-00037
• 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
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• 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): Other; Required Intervention