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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 BRSL011
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of Range of Motion (2032); Arthralgia (2355); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/08/2021
Event Type  Injury  
Event Description
Unable to bend his knee [joint range of motion decreased] unable to walk [unable to walk] removed liquid from the knee [arthrocentesis] unable to bend his knee and was painful/ still in pain and is worse now before getting the injection [arthralgia aggravated] knee became very swollen [swelling of l knee] case narrative: initial information received on 26-oct-2021 from united states regarding an unsolicited valid serious case received from the non-healthcare professional. This case involves a (b)(6) male patient who was unable to bend his knee, unable to walk, his doctor removed liquid from the knee, unable to bend his knee and was painful/ still in pain and is worse now before getting the injection and his knee became very swollen 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 injection, (formulation, batch number, route: unknown) for osteoarthritis in left knee. On (b)(6) 2021, after the latency of 1 day of starting the treatment with hylan g-f 20, sodium hyaluronate, patient was unable to walk (gait disturbance), his knee became very swollen (joint swelling), therefore unable to bend his knee and was painful (joint range of motion decreased) (arthralgia). On (b)(6) 2021, after the latency of 2 days of starting the treatment with hylan g-f 20, sodium hyaluronate, patient's doctor removed liquid from the knee (aspiration joint) (intervention required) from his knee. On (b)(6) 2021, it happened again and on the (b)(6) 2021 the more liquid was removed. The patient was still in pain and was worse now than before getting the injection. The patient had to walk with a cane and had missed work because of his knee action taken: not applicable for all the events. Corrective treatment: cane for unable to walk, removal of liquid from joint swelling, joint range of motion decreased, arthralgia; not reported for rest all the events. Outcome: unknown for unable to bend his knee, removed liquid from the knee; not recovered for rest all the events. Seriousness criteria: disability for unable to walk, intervention required for rest 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 Key12726557
MDR Text Key284815280
Report Number2246315-2021-00169
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,Consumer,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 03/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberBRSL011
Was Device Available for Evaluation? No
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: 11/01/2021 Patient Sequence Number: 1
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