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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]. Severe pain [knee pain. ] stiffness [joint stiffness]. 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 healthcare professional via fda (food and drug administration) (regulatory number: mw5075406). This case concerns a patient (demographics not provided) who experienced severe pain, stiffness and swelling few hours after 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 in 2017, the patient initiated treatment with intra-articular synvisc one injection 6 ml once (batch/lot number: 7rsl021, expiry date: unknown) was injected into both knees for degenerative joint disease. The same day within 4 hours, the patient had severe pain, stiffness, swelling. Corrective treatment: not reported for severe pain, stiffness and swelling outcome: unknown 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 dated 29-mar-2018. This case concerns a patient who received treatment with synvisc one injection from recall lot and later experienced pain, stiffness and swelling. Since events occurred few hours after administration of synvisc one injection, significant temporal relationship can be established. 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 Key10453927
MDR Text Key213247062
Report Number2246315-2020-00116
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 Lot Number7RSL021
Was Device Available for Evaluation? No
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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