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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number 7RSL021
Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problems Arthralgia (2355); No Code Available (3191)
Event Date 11/09/2017
Event Type  Injury  
Event Description
This spontaneous case from united states was received on (b)(6) 2018 from patient's wife. This case concerns a (b)(6) year old male patient who initiated treatment with synvisc one and on the same day was still having pain in it, had swelling, redness, had low grade fever, under 101, on the next day two ounces of fluid removed. The patient reported that it didn't work; also, device malfunction was identified for the reported lot number. No medical history, previous medications, concomitant medications and concurrent conditions were reported. Patient underwent a surgery for neoplasm removal. On (b)(6) 2017, at 12:30 patient received treatment with intra articular synvisc one injection at a dose of 6 ml once for osteoarthritis (batch/ lot number 7rsl021 and expiry date: unknown). On the same day at night, patient ran a low grade fever, under 101 that night along with redness, swelling and pain. On (b)(6) 2017, after a latency of 1 day, the patient went to doctor's office next day and had two ounces of fluid removed. He received cortisone injection. Corrective treatment: corticosteroid injection for still having pain in it, swelling and redness; not reported for other events. Outcome: unknown for all events. Seriousness criteria: required intervention for still having pain in it, swelling and redness and 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 25-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later had redness, swelling and 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 DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater, NJ 08807
9089817289
MDR Report Key7246768
MDR Text Key99792652
Report Number2246315-2018-00235
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,health professional
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
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 Received03/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 02/06/2018 Patient Sequence Number: 1
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