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

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

Patient Problems Stroke/CVA (1770); Paralysis (1997); No Code Available (3191)

Event Type  Injury  

Event Description

Stroke [stroke], completely paralyzed on his right side [right sided paralysis], nonverbal [speech loss], injured/reason for him getting synvisc-one injections [device use in unapproved indication]. Case narrative: this case is cross referenced with case id: (b)(4) (multiple devices) and (b)(4) (cluster case). Initial information received on 12-mar-2019 from united states regarding an unsolicited valid serious case received from patient's wife. This case involves a (b)(6) male patient who experienced stroke, completely paralyzed on his right side, nonverbal and injured/reason for him getting synvisc-one injections, while he using with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one). (latency: unknown). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On (b)(6) 2017, the patient took hylan g-f 20, sodium hyaluronate injection at dosage of 6 ml for once only in 6 months unknown (lot - unk) for injury. On the unknown date, after six weeks of injection, patient developed stroke. It was also reported that he completely paralyzed on his right side and nonverbal. It was also reported that he was injured on duty and was given synvisc one injections. Final diagnosis was injured/reason for him getting synvisc-one injections, nonverbal, completely paralyzed on his right side and stroke. Corrective treatment: not reported for all the events. Outcome: unknown for rest of the events. Seriousness criteria: medically significant for stroke and completely paralyzed on his right side. 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: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 8431907
• MDR Text Key: 139182390
• Report Number: 2246315-2019-00084
• 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,Followup
• Report Date: 11/01/2019

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