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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 9RSL001ZE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ambulation Difficulties (2544); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/01/2020
Event Type  Injury  
Event Description
Was not able to walk, knees became swollen, swelling of r knee, knees drained, arthrocentesis. Case narrative: initial information received on (b)(6) 2021 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study "spon i synvisc one". Patient id: (b)(6); country: (b)(6) study title: patient support program involving synvisc one. This case involves a (b)(6)female patient who was not able to walk, her knees became swollen and her knees drained 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) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection at the dosage of 6 ml for once only via unknown route (lot 9rsl001ze) for osteoarthritis in right knee. On the dec-2020, after the latency of two weeks of starting the treatment with hylan g-f 20, sodium hyaluronate, her knee became swollen (joint swelling) and was not able to walk (gait inability). Her knee was drained (aspiration joint). Action taken: not applicable for all the events. Corrective treatment: not reported for aspiration joint; arthrocentesis for rest both the events. Outcome: recovered for all the events. Reporter causality: related for all the events. Company causality: reportable for all the events.
 
Manufacturer Narrative
Sanofi company comment on (b)(6) 2021: based on the limited information provided regarding this case, causal role of the company suspect product i. E. Hylan g-f 20, sodium hyaluronate in causing unable to walk, joint swelling and arthrocentesis cannot be established. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.
 
Manufacturer Narrative
Sanofi company comment on (b)(6) 2021: based on the limited information provided regarding this case, causal role of the company suspect product i. E. Hylan g-f 20, sodium hyaluronate in causing unable to walk, joint swelling and arthrocentesis cannot be established. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.
 
Event Description
Was not able to walk, knees became swollen, swelling of r knee, knees drained, arthrocentesis. Case narrative: initial information received on (b)(6) 2021 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study "spon i synvisc one". Patient id: (b)(6); country: (b)(6) study title: patient support program involving synvisc one. This case involves a (b)(6)female patient who was not able to walk, her knees became swollen and her knees drained 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) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection at the dosage of 6 ml for once only via unknown route (lot 9rsl001ze) for osteoarthritis in right knee. On the (b)(6) 2020, after the latency of two weeks of starting the treatment with hylan g-f 20, sodium hyaluronate, her knee became swollen (joint swelling) and was not able to walk (gait inability). Her knee was drained (aspiration joint). Action taken: not applicable for all the events. Corrective treatment: not reported for aspiration joint; arthrocentesis for rest both the events. Outcome: recovered for all the events. Reporter causality: related for all the events. Company causality: reportable for all the events.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
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 Key12879386
MDR Text Key285233083
Report Number2246315-2021-00176
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,Study,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Expiration Date11/30/2021
Device Lot Number9RSL001ZE
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: 11/26/2021 Patient Sequence Number: 1
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