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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ Back to Search Results
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Discomfort (2330); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2021
Event Type  Injury  
Event Description
Greenish yellow in color sample of the fluid drained from the injection area after the first injection [arthrocentesis]. Swelling in the injection area after both applications [injection site joint swelling]. Discomfort in the injection area after both applications [injection site joint discomfort]. Greenish yellow in color sample of the fluid drained from the injection area after the first injection [synovial fluid colour]. Received synvisc for swelling in knee via subcutaneous route [drug use via unapproved administration route]. Case narrative: initial information received on 20-jul-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from united states. This case involves a (b)(6) years old male patient who had greenish yellow in color sample of the fluid drained from the injection area after the first injection, swelling in the injection area after both applications, discomfort in the injection area after both applications and received synvisc for swelling in knee via subcutaneous route while being treated with hylan g-f 20, sodium hyaluronate (synvisc). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On (b)(6) 2021, the patient started taking hylan g-f 20, sodium hyaluronate injection (strength: 8 mg/ml) at the dose of 2 ml via subcutaneous route (product use issue) (batch number, indication: unknown). On the unknown of 2021, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced swelling and discomfort in the injection area (injection site joint swelling) (injection site joint discomfort) (medically significant) (intervention required) after both applications doctor drained fluid from the injection area after the first injection caller noted that the fluid was greenish yellow in color sample of the fluid was sent to the lab for testing (aspiration joint) (synovial fluid analysis) (medically significant) (intervention required). Action taken: not applicable for received synvisc for swelling in knee via subcutaneous route; unknown for rest all the events. Corrective treatment: fluid withdrawn for injection site joint swelling; not reported for rest all the events. Outcome: unknown for received synvisc for swelling in knee via subcutaneous route, greenish yellow in color sample of the fluid drained from the injection area after the first injection; recovering for rest both the events.
 
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Brand NameSYNVISC
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 Key12217284
MDR Text Key263546071
Report Number2246315-2021-00128
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 Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
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: 07/23/2021 Patient Sequence Number: 1
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