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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
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.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
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 Key11752961
MDR Text Key264300872
Report Number2246315-2021-00096
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
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 Received04/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
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
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