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

Lot Number UNKNOWN

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/04/2024

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment for follow-up dated (b)(6) 2024: this case involves an unknown-age female patient who had an injection and had an allergic reaction, the knee swelled, it became very hot and a few days ago the doctor had to remove water from that knee with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s medical history, past medications, concomitant medications, underlying conditions, and other risk factors would aid in better case assessment.

Event Description

She had an injection and she had an allergic reaction, the knee swelled, it became very hot and a few days ago the doctor had to remove water from that knee [allergic reaction] ([injection site joint warmth], [injection site joint swelling], [injection site joint effusion]) had to remove water from that knee [arthrocentesis].Case narrative: initial information was received on 19-apr-2024 regarding an unsolicited valid serious case received from the patient.This case involves an unknown age female patient who had an injection and had an allergic reaction, the knee swelled, it became very hot and a few days ago the doctor had to remove water from that knee with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s), and family history were not provided.On 04-apr-2024, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection once (with an unknown dose, route, indication, strength: 48 mg/6ml).The patient called to ask if we can take back her box of synvisc one that she cannot use.She had a problem with both knees and so she bought 2 boxes of synvisc one.15 days ago, she had an injection, and she had an allergic reaction.The knee swelled, and it became very hot (hypersensitivity) (injection site joint warmth) (injection site joint swelling) (onset date: (b)(6) 2024; latency: same day) and a few days ago the doctor had to remove water from that knee (aspiration joint) (onset date: (b)(6) 2024; latency: few days) (unknown: batch number and expiry date).She will therefore not be able to give the second injection, but the pharmacy told her that they cannot take it back.Information on the batch number was not requested.Corrective treatment: the patient had removed water from that knee for hypersensitivity, injection site joint warmth and injection site joint swelling and not reported for aspiration joint.Outcome: unknown for both events.Seriousness criteria: intervention required for both events.

• 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: 19199589
• MDR Text Key: 341237085
• Report Number: 2246315-2024-00026
• 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: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2024

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 Lot Number: UNKNOWN
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2024
• 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): Required Intervention
• Patient Sex: Female