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

Lot Number 7RSL001

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

Patient Problems Erythema (1840); Pain (1994); Joint Swelling (2356); Fluid Discharge (2686)

Event Type  Injury  

Event Description

Redness [injection site erythema].Swelling [knee swelling].Increased pain [knee pain].Fluid drawn [knee effusion].Warm to touch [joint warmth].Case narrative: this case is cross referenced to cases (b)(4) (same reporter).Initial information received on 01-jun-2018 regarding this unsolicited valid case from united states received from a health professional.This case involves a patient with unknown demographics who experienced redness, increased pain, swelling, fluid drawn and warm to touch after he/she was 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 received intra-articular hylan g-f 20, sodium hyaluronate (synvisc one) at an unknown dose and frequency for an unknown indication (lot - 7rsl001 and expiry date: 31-dec-2019).On an unknown date, after receiving hylan g-f 20, sodium hyaluronate (synvisc one) the patient developed redness, increased pain, swelling, fluid drawn and warm to touch.Final diagnosis was warm to touch, fluid drawn, swelling, increased pain and redness.Action taken: unknown.Corrective treatment: steroid (unspecified) for warm to touch, fluid drawn, swelling, increased pain and redness.Outcome: unknown.A pharmaceutical technical compliant (ptc) was initiated on 19-jun-2018 for synvisc one (lot number: 7rsl001); with global ptc number: (b)(4).The production and quality control documentation for lot # 7rsl001, expiration date (2019-12-31) was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot batch record review & lot # frequency analysis for lot 7rsl001, no capa was required.Sanofi global pharmacovigilance and epidemiology continuously monitored 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.As of 09-jul-18 there were 8 complaints on file for lot # 7rsl001 and all related sublots: four (4) adverse event reports, one (1) tip needle breakage, one (1) luer lok hub breakage, one (1) missing syringe and one (1) luer lok hub leakage.Sanofi will continue to monitor complaints to determine if a capa is required.Additional information was received on 11-jul-2018.Lot number of synvisc one was updated from 7rfl001 to 7rsl001 and expiry date was updated from dec-2019 to 31-dec-2019.Global ptc number and results were added.Text was amended accordingly.Information received on 11-jul-2018.No new information.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 7868371
• MDR Text Key: 119951218
• Report Number: 2246315-2018-00579
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/31/2019
• Device Lot Number: 7RSL001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention