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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 Date 11/01/2017
Event Type  Malfunction  
Event Description

This unsolicited case from united states was received on 07-dec-2017 from a non-healthcare professional. This case concerns a female patient of unknown age who received treatment with synvisc one and later few days after starting treatment had pseudo sepsis. No past drug, medical history, concomitant medication or concurrent condition was provided. On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection (dose, frequency and indication: unknown) (batch/lot number: 7rsl021, expiry date: unknown). On (b)(6) 2017, the patient had discomfort. On an unknown date in (b)(6) 2017, few years after starting treatment with synvisc one, the patient was diagnosed with pseudo sepsis requiring 2-3 days in the hospital. The patient called their office on (b)(6) 2017 requesting narcotic pain medications. It was reported that the doctor was not able to prescribe anything due to her being out of state and via telephone recommended her to go to an urgent care for pain medication and treatment. Action taken: unknown. Corrective treatment: not reported. Outcome: unknown. Seriousness criteria: hospitalization/prolongation. A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.

 
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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 Key7156223
Report Number2246315-2017-00285
Device Sequence Number1
Product CodeMOZ
Report Source Manufacturer
Source Type CONSUMER
Remedial Action Recall
Type of Report Initial
Report Date 12/07/2017
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 OTHER
Device LOT Number7RSL021
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2018
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: 12/30/2017 Patient Sequence Number: 1
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