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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 Problem Device Contamination With Biological Material (2908)
Patient Problems Bacterial Infection (1735); Pain (1994); Swelling (2091); Weakness (2145); Toxicity (2333)
Event Date 11/11/2017
Event Type  malfunction  
Event Description
Based on additional information received on 05-dec- 2017, this case was upgraded to serious as an important medical event of device malfunction was added. This unsolicited case from united states was received on 05-dec-2017 from nurse. This case concerns a (b)(6) years old male patient who received treatment with synvisc one injection and after 1 day had increased weakness, swelling in both knees and sharp pains. Also device malfunction was identified for the reported lot number. No medical history, past drug, concomitant medication and concurrent condition was provided. On (b)(6) 2017, patient received treatment with intraarticular synvisc one bilateral injections, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: 31-may-2020; indication: not provided). On (b)(6) 2017, patient called back reporting swelling in both knees, sharp pains, and increased weakness. Corrective treatment: not reported for all events. Outcome: unknown for all events. A global pharmaceutical technical complaint (ptc) was initiated with the global ptc number: (b)(4). An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021. The product met all release testing at time of manufacture in june 2017. Retain samples were retested due to the unexpected increase in adverse events. Higher than expected endotoxin results were obtained. In addition, the presence of microbial contamination was also confirmed. The cause of these events is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Additional information was received on 05-dec-2017 and 18-dec-2017 (both processed with the clock start date of 05-dec-2017). The case was upgraded to serious. Global ptc number and results were added. Additional event of device malfunction was added along with details. Text was amended accordingly. Pharmacovigilance comment: sanofi company comment dated 5-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced lower extremities weakness, swelling of knees nd bilateral knee pain. A temporal relationship can be established with the product administration. Furthermore, the concerned lot number has been identified to have malfunction by the company. Therefore, the causal relationship of the events to the products cannot be excluded.
 
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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 Key7163207
MDR Text Key96616985
Report Number2246315-2017-00562
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
Remedial Action Recall
Type of Report Initial
Report Date 12/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/05/2017
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: 01/04/2018 Patient Sequence Number: 1
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