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 Atrial Fibrillation (1729); Reaction, Injection Site (2442)

Event Date 12/08/2019

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment 21-apr-2020.Follow up information received did not change previous case assessment.This case concerns patient who received treatment with synvisc one and later was diagnosed with atrial fibrillation.Based on limited information provided, causal role of suspect product cannot be excluded.Case will be re-evaluated post further update on the patients underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

Event Description

Atrial fibrillation [atrial fibrillation].Concern regarding bleeding because the needles were large [injection site bleeding].Case narrative: initial information received on 13-apr-2020 from united states regarding an unsolicited valid serious case received from a consumer.This case involves an (b)(6) years old female patient who experienced atrial fibrillation and concern regarding bleeding because the needles were large, 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 in 2019, patient received injection of hylan g-f 20, sodium hyaluronate (dose, frequency, route, indication, batch: unknown) (in the context of covid19 crisis, the batch number and expiration date were not requested).On (b)(6) 2019, patient was diagnosed with atrial fibrillation (latency: unknown) (medically significant) and was taking epixaban (eliquis) as a corrective treatment.Patient stated that the injections usually last longer than 6 months and reported that the synvisc one injections were successful.She reported concern regarding bleeding because the needles were large (onset and latency: unknown).Further, patient stated that she would like to know if she could take synvisc-one with one of her other medications and would like to know if there were any precautions regarding taking eliquis and receiving synvisc one injections.Action taken: not applicable for both events.Corrective treatment: epixaban (eliquis) for atrial fibrillation; not reported for concern regarding bleeding because the needles were large.Outcome: unknown for both events.A pharmaceutical technical complaint (ptc) was initiated on 14-apr-2020 for synvisc one, batch number: unknown with global ptc number: (b)(4).The product lot number was not provided; therefore a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Final investigation was completed on 21-apr-2020.Follow up received on 13-apr-2020 from healthcare professional.Global ptc number added.Additional information was received on 21-apr-2020 from healthcare professional.Ptc results were added.Text was 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: 10017995
• MDR Text Key: 196920460
• Report Number: 2246315-2020-00058
• 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: 04/24/2020

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2020
• 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