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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 Pain (1994); Swelling (2091); No Code Available (3191)
Event Date 11/14/2017
Event Type  Injury  
Event Description
Device malfunction [device malfunction]. Pain [pain]. Swelling [swelling]. Could barely walk [unable to walk]. Case narrative: case was initially submitted via sanofi legacy database and is now being re-distributed to fda at their request. This case was cross referenced with (b)(4) (cluster). This unsolicited case from united states was received on 15-dec-2017 2017 from a pharmacist via health authority i. E fda (with regulatory number mw5073425). This case concerns a patient (demographics unspecified) who received treatment with synvisc one and after unknown latency the patient had pain, swelling and could barely walk, also, device malfunction was identified for the reported lot number. No medical history, concomitant medication or concurrent condition was provided. Past medication included synvisc one and had tolerated it. On an unknown date in 2017, the patient initiated treatment with single intra-articular synvisc one injection, at the dose of 6 ml once (batch/lot number: 7rsl021; expiry date:31-may-2020) for osteoarthritis. On (b)(6) 2017, unknown latency after receiving the injection, the patient had pain, swelling and could barely walk. Corrective treatment: not reported for all. Outcome: unknown for all. 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. Seriousness criterion: important medical event for all pharmacovigilance comment: sanofi company comment dated 09-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later had pain, swelling and could barely walk. 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 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 Key10453923
MDR Text Key213491108
Report Number2246315-2020-00109
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? Yes
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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