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

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  Death  

Event Description

Died [death nos]. So sore that last time he had it [pain]. Case narrative: initial information received on 27-jul-2021 from (b)(6) regarding an unsolicited valid serious case received from a patient wife. This case involves an unknown age male patient who experienced died and so sore that last time he had medical device hylan g-f 20, sodium hyaluronate (synvisc). 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, (dosage and route, lot number unknown) for unknown indication. The patient received 3 synvisc injections and it was so sore (pain) that last time he had it and he never had it again. The patient died more than 10 years ago on an unknown date in 2011. This event was aassessed as medically significant and leading to death. It was unknown if an autopsy was done. The cause of death was reported as death nos. Action taken- unknown it was not reported if the patient received a corrective treatment for the events (so sore that last time he had it, died). At time of reporting, the outcome was unknown for the event so sore that last time he had it and was fatal for the event died.

• Brand Name: SYNVISC
• 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: 12255075
• MDR Text Key: 264393056
• Report Number: 2246315-2021-00133
• 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,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: Yes

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: 07/30/2021 Patient Sequence Number: 1