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

Lot Number UNKNOWN

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment for follow-up dated 14-dec-2020: this case concerns a patient who commenced treatment with synvisc and reported to have developed large effusion in knee.Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded.Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

Event Description

Large effusion right knee [effusion (r) knee].Case narrative: upon internal review with csd of 14-dec-2020, case qualifies for deletion, since identified as a duplicate of (b)(4).Initial information received on 14-dec-2020 regarding an unsolicited valid serious case received from a physician via health authorities of united states under reference mw5097802 and from other healthcare professional.This case involves an unknown age patient who had a large effusion right knee, with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.On an unknown date, the patient received a series of hylan g-f 20, sodium hyaluronate injections, each one week apart via intra-articular route (dose, indication and batch number: unknown) in the right knee.On an unknown date, unknown latency after first injection and 1 week after the last injection, the patient developed a large effusion in the right knee (joint effusion).This event was reported as medically significant.Action taken: not applicable.Corrective treatment: not reported.Outcome: unknown.A product technical complaint (ptc) on 14-dec-2020 for synvisc with unknown bath number and global ptc number: (b)(4) and the results were pending for the same.Upon internal review with csd of 14-dec-2020, case qualifies for deletion, since identified as a duplicate of (b)(4).

• 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: 11064167
• MDR Text Key: 234494834
• Report Number: 2246315-2020-00175
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention