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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 Edema (1820); Arthralgia (2355)
Event Date 11/09/2017
Event Type  Injury  
Event Description
Device malfunction [device malfunction], increased edema in joint [edema knees], pain in joint [joint 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 health authority of united states (us-fda with regulatory reference number: mw5075449). This case involves a patient of unknown demographics who received treatment with synvisc one and later after unknown latency had increased edema in joint and pain in joint. Also device malfunction was identified for the reported lot number. No past drug, medical history, concomitant medication or concurrent condition was provided. On an unknown date in 2017, the initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for bilateral knee pain (batch/lot number: 7rsl021; expiration date: 31-may-2020) for bilateral knee pain. On (b)(6) 2017, after unknown latency, the patient had increased edema and pain in joint. It was reported that the event abated after stopping treatment with synvisc one. Corrective treatment: not reported for all the events. Outcome: recovering for all the events. Seriousness criteria: medically significant for all the 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. Pharmacovigilance comment: sanofi company comment dated 30-mar-18. This case concerns a patient who received treatment with synvisc one from recall lot and later experienced edema in knees and joint pain. Since the date of product of administration is unknown a significant temporal relationship can't be established. However the causal role of suspect product can also not be excluded in occurrence of the event. Furthermore, the concerned lot number has been identified to have malfunction by the company. Moreover due to lack of information regarding medical history, concomitant medications, investigation details and past drugs complete medical assessment of the case is difficult.
 
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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 Key10453933
MDR Text Key213412399
Report Number2246315-2020-00120
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
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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