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

Lot Number ARSL019B

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

Patient Problems Bacterial Infection (1735); Synovitis (2094)

Event Type  Injury  

Event Description

Discovered the bacteria [bacterial infection nos] synovitis [synovitis] case narrative: this case was cross linked to (b)(4) (cluster). Initial information received on 23-sep-2021 regarding an unsolicited valid serious case received from the patient from (b)(6). This case involves an unknown age male patient who experienced synovitis and microbiologist discovered the bacteria while being 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, the patient started taking hylan g-f 20, sodium hyaluronate injection ( indication, dose, route, strength: unknown) (lot - arsl019b, expiry date: 30-apr-2023). On an unknown date after unknown latency patient developed synovitis (seriousness: medically significant and hospitalization). Patient went to see a doctor at and the microbiologist discovered that the bacteria (bacterial infection) was from the product and not from the patient. The patient was currently hospitalized. Action taken with hylan g-f 20, sodium hyaluronate was not applicable. It was not reported if the patient received a corrective treatment for the events (synovitis, discovered the bacteria). At time of reporting, the outcome was unknown for the event synovitis and was unknown for the event discovered the bacteria.

• 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: 12547611
• MDR Text Key: 281022561
• Report Number: 2246315-2021-00160
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: ARSL019B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: 09/29/2021 Patient Sequence Number: 1