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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 (2908); Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 11/09/2017
Event Type  malfunction  
Event Description
This legal spontaneous case from united states was received on (b)(6) 2018 from the patient's lawyer (other non healthcare professional). This case concerns a (b)(6) female patient who initiated treatment with synvisc one and the same day had pain/ hurts little bit. Also device malfunction was identified for the reported lot number. No previous medications were reported. The patient had no known drug allergies. Patient was a non-smoker. Medical history included arthritis, back pain and thyroid problems. The patient also had hypertension. Concomitant medications included paracetamol (acetaminophen), codeine, azelastine, azithromycin, calcitonin, celecoxib, cefalexin (cephalexin), chlorhexidine gluconate, metronidazole, pantoprazole, alirocumab, (praluent), promethazine hydrochloride (promethazine), levothyroxine sodium (synthroid), amlodipine/telmisartan and tramadol hydrochloride (tramadol). Marital status: married. The patient had history of knee crepitus and edema. On (b)(6) 2017, patient received treatment with intra articular synvisc one injection (unknown dose) (batch/ lot number: 7rsl021 and expiry date: may-2020) to her right knee for osteoarthritis of knee/unilateral primary osteoarthritis, right knee. The patient brought the injection in with her. Patient reported no fever, no night sweats, no significant weight gain or weight loss and no exercise intolerance. The patient had a healthy female musculoskeleton. She reported no abnormal mole, no jaundice and no rashes. The patient tolerated the procedure well and was instructed to avoid strenuous activity for 24-48 hours and to use ice, nsaids or paracetamol (tylenol) for pain as needed. The same day, patient had pain and it hurt a little bit. The patient continued to wear the unloader brace. Corrective treatment: brace for pain/ hurts little bit outcome: unknown for both events seriousness criteria: important medical event for device malfunction 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. Pharmacovigilance comment: sanofi company comment dated (b)(6) 2018: this case concerns a patient who suffered from right knee pain after receiving synvisc one injection from the recalled lot. Temporal relationship can be established between the events and the suspect product based on the available information. Additionally, as the concerned lot number has been identified to have malfunction by the company. Therefore, pharmacological plausibility of the event to the product 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 Key7446119
MDR Text Key106971767
Report Number2246315-2018-00452
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 consumer
Reporter Occupation Patient
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/01/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/11/2018
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: 04/20/2018 Patient Sequence Number: 1
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