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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 UNKNOWN
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
Was late in receiving next injection with no reported adverse event [inappropriate schedule of product administration]. Case narrative: initial information received on 08-jan-2021 regarding an unsolicited valid serious case received from patient via health authorities of united states under reference fda tracking number: mw5097930. This case involves patient of unknown demographics who had treatment with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and was late in receiving next injection with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate, (dosage, formulation, lot number, frequency, indication: unknown) via intra-articular route. On the unknown date, after unknown latency of initiating the treatment with hylan g-f 20, sodium hyaluronate, patient was late in receiving next injection with no reported adverse event (inappropriate schedule of product administration) (medically significant). Action taken: not applicable. Outcome: not applicable. A product technical complaint was initiated with 08-jan-2021 for synvisc with unknown batch number and global ptc number (b)(4). The product lot number was not provided; therefore, a batch record review was not possible. It was the requirement to review all finished batch records for specification conformance prior to release. Any out of specification result was identified and mitigated through the ncr (non-conformances report) process. Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals. This review has not indicated any safety issue. Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required. Investigation completion date: 01-feb-2021 follow up received on 08-jan-2021 from healthcare professional. Global ptc number was added. Text amended accordingly. Additional information was received on 01-feb-2021 from healthcare professional. Investigational results were added. Text amended accordingly.
 
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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 Key11299532
MDR Text Key244054650
Report Number2246315-2021-00066
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 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
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: 02/09/2021 Patient Sequence Number: 1
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