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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 9RSL023Z
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2021
Event Type  Injury  
Event Description
Joint infection, swelling of l knee, aching (l) knee, unable to walk. Case narrative: initial information received on (b)(6) 2021 regarding a solicited valid serious case received from a consumer/non-hcp, in the scope of post-marketing sponsored study "spon i synvisc one". Patient id: unknown; country: (b)(6). Study title: patient support program involving synvisc one. This case involves a (b)(6) male patient who experienced infection and was unable to walk 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 at the dose of 6 ml for once only via unknown route (lot 9rsl023z) for osteoarthritis in the left knee and meniscus injury. On the unknown route of 2021, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had a severe reaction to the injection. His knee became swollen (joint swelling), was unable to walk (gait inability) (intervention required), lots of pain (arthralgia) and possible infection (arthritis infective) (medically significant). Patient got surgery to clean out his knee. Action taken: not applicable for all the events. Corrective treatment: surgery for all the events. Outcome: recovered for all the events. Reporter causality: not reported for all the events. Company causality: reportable for all the events.
 
Event Description
Joint infection, swelling of l knee, aching (l) knee, unable to walk. Case narrative: initial information received on (b)(6) 2021 regarding a solicited valid serious case received from a consumer/non-hcp, in the scope of post-marketing sponsored study "spon i synvisc one". Patient id: unknown; country: (b)(6). Study title: patient support program involving synvisc one. This case involves a (b)(6) male patient who experienced infection and was unable to walk 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 at the dose of 6 ml for once only via unknown route (lot 9rsl023z) for osteoarthritis in the left knee and meniscus injury. On the unknown route of 2021, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had a severe reaction to the injection. His knee became swollen (joint swelling), was unable to walk (gait inability) (intervention required), lots of pain (arthralgia) and possible infection (arthritis infective) (medically significant). Patient got surgery to clean out his knee. Action taken: not applicable for all the events. Corrective treatment: surgery for all the events. Outcome: recovered for all the events. Reporter causality: not reported 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 Key12875981
MDR Text Key285177277
Report Number2246315-2021-00174
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 Lot Number9RSL023Z
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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