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

Was late in receiving next injection with no reported adverse event [inappropriate schedule of product administration]. Case narrative: initial information received on 08-jan-2021 regarding an unsolicited valid serious case received from patient via health authorities of united states under reference fda tracking number: mw5097930. This case involves patient of unknown demographics who had treatment with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and was late in receiving next injection with no reported adverse event. 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, (dosage, formulation, lot number, frequency, indication: unknown) via intra-articular route. On the unknown date, after unknown latency of initiating the treatment with hylan g-f 20, sodium hyaluronate, patient was late in receiving next injection with no reported adverse event (inappropriate schedule of product administration) (medically significant). Action taken: not applicable. Outcome: not applicable. A product technical complaint was initiated with 08-jan-2021 for synvisc with unknown batch number and global ptc number (b)(4). The product lot number was not provided; therefore, a batch record review was not possible. 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 (non-conformances report) process. Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals. This review has not indicated any safety issue. Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required. Investigation completion date: 01-feb-2021 follow up received on 08-jan-2021 from healthcare professional. Global ptc number was added. Text amended accordingly. Additional information was received on 01-feb-2021 from healthcare professional. Investigational results were added. 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: 11299532
• MDR Text Key: 244054650
• Report Number: 2246315-2021-00066
• 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,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• 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 Treatment Data

Date Received: 02/09/2021 Patient Sequence Number: 1