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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 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, her knees became swollen, 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 left 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.
 
Event Description
Was not able to walk, her knees became swollen, 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 left 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 Key12876021
MDR Text Key285177601
Report Number2246315-2021-00175
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 Received11/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Expiration Date11/01/2021
Device Lot Number9RSL001ZE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? 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: 11/25/2021 Patient Sequence Number: 1
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