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 Problem Cancer (3262)

Event Type  Injury  

Event Description

Metastatic melanoma/ melanoma that has spread to the lungs [metastatic malignant melanoma] ([metastases to lung]). Case narrative: initial information was received from (b)(6) on 22-apr-2021 regarding an unsolicited valid serious case from a physician (physiatrist). This case involves a (b)(6) years old patient (gender: unknown) who experienced metastatic melanoma/ melanoma that has spread to the lungs after 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. In 2020, the patient started taking synvisc one (hylan g-f 20, sodium hyaluronate) injection (with an unknown batch number, dose, frequency, route, and indication). Information on batch number was requested. It was reported that the patient's only hobby was walking and a year ago (2020), when there was no melanoma diagnosis yet, synvisc one was injected. On an unknown date, after unknown latency, the patient was diagnosed with metastatic melanoma (metastatic malignant melanoma). The patient was undergoing palliative care at home and had no pain from melanoma that has spread to the lungs (metastases to lung). This event was assessed as medically significant. The patient would like a synvisc one injection into the knee. The reporting physician could not find a contraindication for injection from the informative label but was still terrified and asked for the opinion. The patient had an appointment on 28-apr-2021. Action taken: not applicable. Corrective treatment: undergoing palliative care at home. At time of reporting, the outcome was unknown. A product technical complaint (ptc) was initiated on 22-apr-2021 for synvisc one; batch number: unknown; global ptc number: (b)(4) and results were pending for the same.

• 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: 11752961
• MDR Text Key: 264300872
• Report Number: 2246315-2021-00096
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

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: 04/30/2021 Patient Sequence Number: 1