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

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

Patient Problem Stroke/CVA (1770)

Event Type  Injury  

Event Description

Stroke [stroke]. Case narrative: this case is cross referenced with case: (b)(4) (cluster case). Initial information received on 12-mar-2019 from united states regarding an unsolicited valid serious case received from a non-healthcare professional this case involves a (b)(6) male patient who experienced stroke, 2 days after, he used the medical device of 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 took hylan g-f 20, sodium hyaluronate injection at unknown dosage unknown frequency via intra-articular route (lot number- unknown) for unknown indication. On the unknown date, patient experienced a stroke after 2 days of injection. Final diagnosis was stroke. Corrective treatment: not reported for stroke. Outcome: unknown for stroke. Seriousness criteria: medically significant for stroke. A product technical complaint was initiated, and results were pending for same.

• 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: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 8431954
• MDR Text Key: 139182702
• Report Number: 2246315-2019-00094
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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: 03/19/2019 Patient Sequence Number: 1