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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE MOZ

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number 7RSL021
Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problems Erythema (1840); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
Event Date 11/22/2017
Event Type  malfunction  
Event Description
This unsolicited case from united states was received on 30-apr-2018 and 01-may-2018 from the patient, both the information was processed together with clock start date 30-apr-2018. This case involves a patient (demographics: not provided) who received treatment with synvisc one and after few days the patient had trouble walking, knee pain, knee redness and knee swelling (after unknown latency). Also, device malfunction was identified for the reported lot number. No medical history, past drugs, concurrent condition was provided. Concomitant medications included simvastatin, amlodipine, alprazolam, metoprolol tartrate (metoprolol), fish oil, low dose acetylsalicylic acid (aspirin). On an unknown date in (b)(6) 2017, the patient initiated treatment with intra-articular, injection (dose: not provided; batch/lot number: 7rsl021) for pain relief for knee. It was reported that the patient had an injection of synvisc one which was from a contaminated lot, lot #7rsl021. On (b)(6) 2017 (after unknown latency), the patient experienced pain, swelling, redness, trouble walking, was later called by physician to be informed of the contamination. The patient had to go to the hospital for blood tests, apparently the blood tests were satisfactory. The blood tests were done a month later but had lesser levels of pain and swelling for 2 months. It was reported that the problem did not stop after the patient reduced the dose or stopped taking or using the product. Corrective treatment: not reported for all events outcome: recovering for device malfunction was identified for the reported lot number, knee pain, knee swelling; unknown for rest of the events. Seriousness criterion: medically significant for all events. A product technical complaint (ptc) was initiated and results were pending for the same. 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-apr-2018: this case concerns a patient who suffered from pain, swelling of knee, knee redness and trouble walking after receiving synvisc one injection from the recalled lot. Temporal relationship can be established between the events and the suspect product based on the available information. Additionally, as the concerned lot number has been identified to have malfunction by the company, therefore, pharmacological plausibility of the events to the product cannot be excluded.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
a
bridgewater, NJ 08807
9089817289
MDR Report Key7510668
MDR Text Key108733512
Report Number2246315-2018-00475
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 09/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/30/2018
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: 05/14/2018 Patient Sequence Number: 1
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