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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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/11/2021
Event Type  Injury  
Manufacturer Narrative
Sanofi company comment dated (b)(6) 2021: this case concerns a patient who received treatment with hylan g-f 20, sodium hyaluronate but had amyotrophic lateral sclerosis later. Based on the lack of information, causal relationship of the device in the occurrence of events cannot be denied. However, further information regarding patient¿s concomitant medications and technique used while administration of injection precludes complete medical assessment of the case.
 
Event Description
Als (amyotrophic lateral sclerosis) [als]. Case narrative: initial information received on 18-nov-2021 regarding an unsolicited valid serious case received from other health professional from united states. This case involves an unknown age and unknown gender patient who experienced als (amyotrophic lateral sclerosis) with the use of medical device 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 using hylan g-f 20, sodium hyaluronate solution for injection once (dose, route, strength, indication, batch number and expiry date: unknown). On (b)(6) 2021 patient was diagnosed with als (amyotrophic lateral sclerosis) (amyotrophic lateral sclerosis) (unknown latency) after starting use of hylan g-f 20, sodium hyaluronate. This event was assessed as medically significant. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the event (als (amyotrophic lateral sclerosis)). At time of reporting, the outcome was unknown for the event als (amyotrophic lateral sclerosis).
 
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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 Key12879341
MDR Text Key285985985
Report Number2246315-2021-00177
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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: 11/26/2021 Patient Sequence Number: 1
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