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

Lot Number 7RSL047

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

Patient Problem Death (1802)

Event Date 05/24/2018

Event Type  Death  

Event Description

Patient passed away unexpectedly [death nos].Case narrative: upon internal review on 7-jun-2018, this case was found out to be a duplicate of (b)(4), hence prepared for deletion.Initial information was received on 07-jun-2018 regarding this unsolicited case from united states via a health professional.This case involves a patient of unknown demographics who passed away unexpectedly (latency: unknown), after he/she was treated with 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 in 2018, the patient received intra-articular hylan g-f 20, sodium hyaluronate (synvisc one) injection once at a dose of 6 ml (lot - 7rsl047, exp date: 31-oct-2020) for unilateral primary osteoarthritis.On (b)(6) 2018, the patient passed away unexpectedly following the first dose intake.Final diagnosis was (fatal) patient passed away unexpectedly.It is unknown if an autopsy was done.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 7927019
• MDR Text Key: 122373236
• Report Number: 2246315-2018-00640
• 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
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/31/2020
• Device Lot Number: 7RSL047
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death