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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 BRSL015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
Experienced swelling and came back in for aspiration and checked for infection [knee effusion]. Experienced swelling and came back in for aspiration and checked for infection [arthrocentesis]. Experienced swelling and came back in for aspiration and checked for infection [knee swelling]. Pseudosepsis [pseudosepsis]. Case narrative: initial information received on 10-sep-2021 regarding an unsolicited valid serious case received from a other health professional from united states. This case is linked to cases (b)(4) and (b)(4). This case involves a (b)(6) year-old male patient who experienced swelling and came back in for aspiration and checked for infection, and pseudo sepsis 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, (formulation, dosage, route, indication: unknown) (lot number:brsl015,expiration date :2024-04-01). On the unknown date, after unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced pseudo sepsis (pseudosepsis). Patient experienced swelling and came back in for aspiration and checked for infection, (joint effusion) (aspiration joint) (intervention required) (joint swelling). She had cultures which were negative and gradually resolved with anti-inflammatories. Action taken: unknown for all the events. Corrective treatment: anti-inflammatories for all the events. Outcome: recovered for all the 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 Key12473859
MDR Text Key271461456
Report Number2246315-2021-00147
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
Report Date 09/30/2021
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 NumberBRSL015
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: 09/15/2021 Patient Sequence Number: 1
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