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

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

Patient Problems Pain (1994); Swelling (2091)

Event Date 11/21/2012

Event Type  Injury  

Event Description

Pain (legs) [pain legs].Leg were swollen [swelling of legs].Case narrative: initial information was received on 14-dec-2020 regarding an unsolicited valid serious case from health authorities of united states under reference mw5097910 via pharmacist.This case involves an unknown age female patient who experienced leg were swollen and pain (legs), while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.On (b)(6) 2012, the patient received hylan g-f 20, sodium hyaluronate injection via intra-articular route (strength: 48mg/6ml) (dose, frequency, indication and batch number unknown).There will be no information available on the batch number of this case.On (b)(6) 2012 , next day after latency of 1 day, patient's legs were swollen (peripheral swelling) (medically significant) and she applied ice on it which did not help.On an unknown date in (b)(6) 2012, patient went to emergency room where they drained her legs which relieved her pain (onset: (b)(6) 2012 and latency 1 day) (pain in extremity: medically significant) and swelling on an unknown date in (b)(6) 2012.Action taken: not applicable for both events corrective treatment: applied ice and drained her legs for both events the patient outcome is reported as recovered for both events a product technical compliant (ptc) was initiated on 14-dec-2020 for synvisc one with unknown batch number and global ptc number: (b)(4).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 (non-conformance) 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 as stated in sop (b)(4)" product event handling" to determine if a capa is required.Final investigation was completed on 23-dec-2020.Follow up was received on 14-dec-2020 from healthcare professional.Global ptc number added.Text amended accordingly.Additional information was received on 23-dec-2020 from other healthcare professional: ptc results were received and added to the case.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: 11087690
• MDR Text Key: 230779051
• Report Number: 2246315-2020-00188
• 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: 12/29/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2020
• 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): Other; Required Intervention