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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 Urticaria (2278); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
Experienced hives on the side of his right knee and back [hives]. He felt as if his throat would shut [throat discomfort]. Case narrative: initial information received on 08-sep-2021 from (b)(6) regarding an unsolicited valid serious case received from a patient. This case involves an unknown age male patient who experienced hives on the side of his right knee and back and he felt as if his throat would shut 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, dosage, frequency, route unknown (lot - unk) for arthritis in the knee. The information regarding lot number was requested. On an unknown date, post second injection, the patient experienced hives on the side of his right knee and back (urticaria), he stated he ended up going to the emergency room to seek treatment because he felt as if his throat would shut (oropharyngeal discomfort), he was prescribed steroids, he stated his doctor dismissed the possibility of an allergic reaction, the patient was afraid of receiving another injection and experiencing the same reaction but thought the product worked very well. These events were leading to intervention. Reportedly, when the patient received his first injection of 5 and it was wonderful. Action taken- not applicable. Corrective treatment: prescribed steroids. At time of reporting, the outcome was unknown for both events.
 
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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 Key12473128
MDR Text Key271455953
Report Number2246315-2021-00146
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,health professional
Type of Report Initial,Followup,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
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 Answer Provided
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: 09/15/2021 Patient Sequence Number: 1
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