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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
Lot Number 7RSL021
Device Problems Device Contamination With Biological Material; Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction  
Event Description

This unsolicited case from united states was received on (b)(6) 2017 from a healthcare professional. This case concerns a (b)(6) female patient who received treatment with synvisc one and later after unknown latency had infection, had elevated pain, extreme pain, stiffness, joint swelling and had joint aspiration. No past drug, medical history, concomitant medication or concurrent condition was provided. On an unknown date, the patient initiated treatment with intra-articular synvisc one injection (dose, frequency and indication: unknown) (batch/lot number: 7rsl021; expiry date: may-2020). On an unknown date, after unknown latency the patient had elevated pain (extreme pain), stiffness, joint swelling, infection and joint aspiration. On an unknown date, after unknown latency the patient had to go get a surgery for infection and had to get synvisc one flushed out. Action taken: unknown corrective treatment: surgery and synvisc one flushed out for infection; synvisc one flushed out for rest of the events outcome: unknown for all the events seriousness criteria: required intervention for all the events a pharmaceutical technical complaint (ptc) was initiated and ptc results were pending. Pharmacovigilance comment: sanofi company comment dated 14-dec-2017: this case concerns a patient who received synvisc one injection and later had infection for which patient had surgery. Based upon the information available, the causal role of the product cannot be denied for the occurrence of events. However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection. Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors will aid in complete medical 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 Key7156224
Report Number2246315-2017-00284
Device Sequence Number1
Product CodeMOZ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Remedial Action Recall
Type of Report Initial
Report Date 12/08/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT Number7RSL021
Was Device Available For Evaluation? No Answer Provided
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/08/2017
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: 12/30/2017 Patient Sequence Number: 1
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