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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 8RSL058G
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Swelling/ Edema (4577)
Event Date 01/01/2019
Event Type  Injury  
Event Description
Had too have liquid removed surgically 5x [joint effusion]. Was not able to stand on it [difficulty in standing]. Her right knee became swollen [swelling of r knee]. Right knee became swollen, there was intense pain [aching (r) knee]. Case narrative: initial information received on 03-may-2022 regarding a solicited valid serious case received from a consumer/non-healthcare professional, in the scope of post-marketing sponsored study "spon_i_synvisc one". Patient id: (b)(6); country: (b)(6). Study title: patient support program involving synvisc one. This case involves adult female patient who experienced had too have liquid removed surgically 5x, her right knee became swollen, right knee became swollen, there was intense pain and was not able to stand on it 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 in (b)(6) 2019, the patient started using hylan g-f 20, sodium hyaluronate injection formulation, dosage, route, frequency unknown (lot and expiry date - unknown) for osteoarthritis right knee. The information regarding lot number was requested. The patient had both knees injected for osteoarthritis. On an unknown date, after couple of weeks from the injection, the right knee became swollen (joint swelling), there was intense pain (arthralgia), was not able to stand on it (dysstasia) and had too have liquid removed surgically 5x (joint effusion; seriousness criteria: intervention required). The patient has had surgery since then. Corrective treatment- liquid removed surgically 5x- had too have liquid removed surgically 5x. It was not reported if the patient received a corrective treatment for the events (right knee became swollen, there was intense pain, was not able to stand on it). At time of reporting, the outcome was recovered / resolved for all events.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
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 Key14485737
MDR Text Key294784724
Report Number2246315-2022-00049
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,Study,Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2021
Device Lot Number8RSL058G
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: 05/24/2022 Patient Sequence Number: 1
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