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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cellulitis (1768)
Event Type  Injury  
Event Description
This unsolicited case from united states was received on (b)(6) 2017 from a healthcare professional (physicians assistant). This case concerns a female patient of unknown age who received treatment with synvisc one and after unknown latency had contracted cellulitis. No medical history, past drugs, concomitant medication or concurrent condition was reported. On an unknown date, the patient received treatment with intra-articular synvisc one injection (dose, frequency and indication: not reported) into unspecified location. On an unknown date, after unknown latency, the patient was said to have contracted cellulitis. The patient was said to need between 3 and 6 days of hospitalization, and received intravenous (i. V. ) antibiotics through a peripherally inserted central catheter (picc) line. No time-frame was provided to the occurrence of the injection, or the follow-up hospitalization. Corrective treatment: iv antibiotics. Outcome: unknown. Seriousness criterion: hospitalization a pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4). The product lot number was not provided; therefore, a batch record review was not possible. Based on the lack of information provided, no capa was required. 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 process. Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals. This review had not indicated any safety issue. Sanofi would continue to monitor adverse events to determine if a capa was required. Additional information was received on (b)(6) 2018. Global ptc number and ptc results added. Text was amended accordingly. Pharmacovigilance comment: sanofi company comment follow up dated (b)(6) 2018: the follow-up received does not change the previous assessment of the case. This case concerns a patient who received treatment with synvisc one injection and later experienced to have cellulitis. Based on the available information, temporal relationship cannot be established between the event and the suspect product. However, information regarding latency, injected lot number, injection technique used, past drugs, concomitant medications and other risk factors is required for further case assessment.
 
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Brand NameSYNVISC ONE
Type of DeviceINTRA-ARTICULAR HYALURONIC ACID
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleadantview terrace
ridgefield NJ 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive
55b-220a
bridgewater, NJ 08807
9089817289
MDR Report Key7217979
MDR Text Key98167280
Report Number2246315-2018-00138
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 12/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/07/2018
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/25/2018 Patient Sequence Number: 1
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