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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)
Event Date 11/09/2017
Event Type  Injury  
Manufacturer Narrative
Sanofi company comment follow up dated 21-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced swelling and pain. 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.
 
Event Description
Device malfunction [device malfunction]. Swelling [injection site swelling]. Pain [injection site pain]. 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 non-healthcare professional via fda (food and drug administration) (regulatory number: ((b)(4)). This case concerns a patient (demographics not provided) who experienced swelling and pain after unknown latency of receiving treatment with synvisc one. Also device malfunction was identified for the reported lot number. No relevant medical history, past drugs, concomitant medication or concurrent condition was provided. On an unspecified date, the patient initiated treatment with intra-articular synvisc one injection 6 ml (48 units) once (batch/lot number: 7rsl021, expiry date: 31-may-2020) for right knee pain in right knee. On (b)(6) 2017 after unknown latency, the patient experienced swelling and pain 5xs ,as a result of injection. Corrective treatment: not reported for swelling and pain. Outcome: recovered for all events. 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 would be completed, corrective and preventive actions would be implemented. Seriousness criteria: medically significant for all events. Pharmacovigilance comment: sanofi company comment follow up dated 21-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced swelling and pain. 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.
 
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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 Key10453924
MDR Text Key213232719
Report Number2246315-2020-00106
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 consumer
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? No Answer Provided
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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