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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 Problems Cellulitis (1768); Unspecified Infection (1930)
Event Date 01/01/2015
Event Type  Injury  
Event Description
This case is cross referenced with case: (b)(4). This unsolicited device case from united states was received on 17-dec-2015 from a nurse. This case concerns a male patient of unknown age who experienced cellulitis infection and staph infection after receiving treatment with synvisc one. No past drug, medical history or concurrent condition was provided. The patient's concomitant medications included triamcinolone acetonide (kenalog) and lidocaine (from multi dose vials). On an unknown date in (b)(6) 2015, the patient initiated treatment with intra-articular synvisc one injection once (dose, indication, batch/lot number and expiration date: not provided). On unknown dates, within the few days of injection the patient developed cellulitis infection and staph infection. Corrective treatment: not reported for both the events. Outcome: unknown for both the events. A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending. Seriousness criteria: important medical event (ime) for both the events. Pharmacovigilance comment: sanofi company comment dated 21-dec-2015: this case concerns a patient who received injection of synvisc one and experienced staphylococcal infection and cellulitis. The causal role of the product in the occurrence of the event cannot be denied completely, however, there is no information regarding the site of infection and the nature of event. Also, lack of information regarding concurrent condition and risk factors precludes a comprehensive assessment of this case.
 
Event Description
This case is cross referenced with case: (b)(4) (cluster). This unsolicited device case from united states was received on 17-dec-2015 from a nurse. This case concerns a male patient of unknown age who experienced cellulitis infection and staph infection after receiving treatment with synvisc one. No past drug, medical history or concurrent condition was provided. The patient's concomitant medications included triamcinolone acetonide (kenalog) and lidocaine (from multi dose vials). On an unknown date in (b)(6) 2015, the patient initiated treatment with intra-articular synvisc one injection once (dose, indication,batch/lot number and expiration date: not provided). On unknown dates, within the few days of injection the patient developed cellulitis infection and staph infection. Corrective treatment: not reported for both the events. Outcome: unknown for both the events. 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. Genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed 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. Genzyme biosurgery would continue to monitor adverse events to determine if a capa was required. Seriousness criteria: important medical event (ime) for both the events. Additional information was received on 22-dec-2015. Ptc results were added and the text was amended accordingly. Pharmacovigilance comment: sanofi company comment for follow up dated 22-dec-2015: the follow up information does not change the prior case assessment. Sanofi company comment dated 21-dec-2015: this case concerns a patient who received injection of synvisc one and experienced staphylococcal infection and cellulitis. The causal role of the product in the occurrence of the event cannot be denied completely, however, there is no information regarding the site of infection and the nature of event. Also, lack of information regarding concurrent condition and risk factors precludes a comprehensive assessment of this case.
 
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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
kristen sharma
55 corporate drive
55c-235a
bridgewater, NJ 08807
9089812784
MDR Report Key5339817
MDR Text Key34882545
Report Number2246315-2015-98623
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2015
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: 01/03/2016 Patient Sequence Number: 1
Treatment
LIDOCAINE(CON.)
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