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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 Problems Arthralgia (2355); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/01/2021
Event Type  Injury  
Event Description
After the injection her knee blew up immediately, that she iced the knee for 2 days, had swelling, a big lump on the left side of the knee [swelling of l knee] pain so she iced it for 2 days/painful for a month [aching (l) knee] who drained the fluid [knee effusion] she couldn't walk for a month [unable to walk]. Case narrative: initial information received on 15-oct-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from united states. This case involves (b)(6) female patient who reported that after the injection her knee blew up immediately, that she iced the knee for 2 days, had swelling, a big lump on the left side of the knee, pain so she iced it for 2 days/painful for a month, she couldn't walk for a month and who drained the fluid 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 (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate solution for injection at a dose of 6 ml once (route, strength, batch number and expiry date: unknown) for osteoarthritis. On (b)(6) 2021 the patient knee blew up immediately, that she iced the knee for 2 days, had swelling, a big lump on the left side of the knee (joint swelling; seriousness: intervention required; latency: same day) and had pain so she iced it for 2 days but the swelling didn't go down (arthralgia; seriousness: intervention required; onset: (b)(6) 2021 and latency: few days). It was reported that patient could not walk (gait inability; onset: (b)(6) 2021 and latency: few days). On an unknown date in (b)(6) 2021, the patient went back to her doctor who drained the fluid (joint effusion; seriousness: intervention required and medically significant; latency: unknown), gave her cortisone and now she was much better. Patient reported that she was never getting the injection again. Action taken: not applicable for all events. Corrective treatment: cortisone and ice for joint swelling; arthralgia and joint effusion; not reported for gait inability. Outcome: recovering for all events.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
MDR Report Key12704715
MDR Text Key284314222
Report Number2246315-2021-00168
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 consumer
Type of Report Initial
Report Date 10/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
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: 10/27/2021 Patient Sequence Number: 1
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