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 Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Experience physical difficulty [physical impairment].Adverse reaction [adverse reaction].Case narrative: initial information received on 21-dec-2021 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp (non health care professional).This case involves adult female patient who experienced physical difficulty and adverse reaction 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, injection, strength: 48mg/6ml (dosage, batch number, route, indication, frequency: unknown).On an unknown date and latency, the patient experienced an adverse reaction the after starting use of hylan g-f 20, sodium hyaluronate.Upon follow-up, it was reported that since an unknown date and latency, the patient experienced moderate physical difficulty (physical disability, seriousness criteria: disability), which the patient believed was attributable to the synvisc injection.Action taken: unknown for both the events.It was not reported if the patient received a corrective treatment for the events.At time of reporting, the outcome was unknown for the event adverse reaction and not recovered for physical disability.A product technical complaint (ptc) was initiated on 21-dec-2021 for synvisc one, batch number; unknown, with global ptc number: (b)(4).The final investigation for the ptc was completed on 03-jan-2022.It was reported that 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 actions) 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 (full form not specified) process.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.Additional information was received on 21-dec-2021 from an other health care professional.Global ptc number and results were added.Strength added.Additional information was received on 03-jan-2022 from an other health care professional.Ptc added.Additional information was received on 22-mar-2022 from the patient.The case was upgraded from non-serious to serious due to addition of the event of physical disability with seriousness criteria: disability.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: 13930314
• MDR Text Key: 288049364
• Report Number: 2246315-2022-00026
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2022

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2022
• 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): Disability
• Patient Sex: Female