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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 Problem Microbial Contamination of Device (2303)
Patient Problems Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
Event Date 01/01/2017
Event Type  Injury  
Event Description
Device malfunction [device malfunction]. Unable to fully bear weight on knees [weight bearing difficulty]. Knee pain [knee pain]. Knee swelling [knee swelling]. Case narrative: case was initially submitted via sanofi legacy database and is now being re-distributed to fda at their request. This unsolicited case from united states was received on 21-mar-2018 from a nurse via health authority (usafda: food and drug administration; reference number: mw5075402) this case involves a male patient (age not provided) who received treatment with synvisc one and after unknown latency was unable to fully bear weight on knees, knee pain, knee swelling. Also, device malfunction was identified for the reported lot number. No relevant medical history, past drugs, concomitant medications and concurrent conditions were reported. On an unknow date in 2017, the patient receive treatment with intra-articular synvisc one, injection (batch/lot number: 7rsl021; expiration date: 31-may-2020; dose not provided) for osteoarthritis of bilateral knees. On an unknown date, after unknown latency, at 2 am, the patient woke up with severe bilateral knee pain and swelling. The patient reported that he was unable to fully bear weight on his knees(onset date: 2017; latency: unknown). Corrective treatment: not reported for all the events. Outcome: unknown for all the events. Seriousness criteria: medically significant for all the events. A product technical complaint was initiated with following results: 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 was under investigation. Once this investigation is completed, corrective and preventive actions would be implemented. Pharmacovigilance comment: sanofi company comment dated (b)(6) 2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later had pain in both knees, knee swelling, and weight bearing difficulty. A temporal relationship cannot be established with the product administration, but since 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. Further information regarding complete medical history, any concomitant or past medications and any concurrent medical conditions will aid in comprehensive assessment of this case.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key10453919
MDR Text Key213231588
Report Number2246315-2020-00105
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial
Report Date 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2020
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 Answer Provided
Was the Report Sent to FDA?
Event Location No Information
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/26/2020 Patient Sequence Number: 1
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