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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 Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
Reaction at the injection site with swelling of the knee [injection site swelling], took out synvisc one and added steroid [aspiration joint]. Case narrative: initial information received on 21-sep-2021 regarding an unsolicited valid serious case received from a physician from united states. This case involves a (b)(6) female patient who experienced reaction at the injection site with swelling of the knee and took out synvisc one and added steroid 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, injection, (formulation, batch number, route, indication: unknown). On the unknown date, after 1 day of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced reaction at the injection site with swelling of the knee (injection site swelling) (intervention required) and took out synvisc one and added steroid (aspiration joint) (intervention required). Action taken: unknown for both the events. Corrective treatment: steroids and aspiration for both the. Outcome: recovering for reaction at the injection site with swelling of the knee; unknown for took out synvisc one and added steroid.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
MDR Report Key12530556
MDR Text Key282332573
Report Number2246315-2021-00156
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
Type of Report Initial,Followup,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
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
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/24/2021 Patient Sequence Number: 1
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