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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 Pain (1994); Loss of Range of Motion (2032); Arthralgia (2355); Joint Swelling (2356); Reaction, Injection Site (2442); No Code Available (3191)
Event Type  malfunction  
Event Description
Based on information received on 24-apr-2018, the report previously considered as non-valid became valid as the additional events of device malfunction, could not bend, severe pain in knee/ pain significantly worse after reaction and significant swelling in knee were added. Additionally, this case initially considered as non-serious was upgraded to serious (important medical event of device malfunction was added). This unsolicited case from united states was received on 23-jan-2018 from patient. This case concerns a (b)(6) female patient who initiated treatment with synvisc one and after an unknown latency, could not bend, severe pain in knee/ pain significantly worse after reaction and had significant swelling in knee and also had issue on long term basis since receiving synvisc-one. Additionally, the device malfunction was reported for the lot number used. No previous medications, medical history, concomitant medications and concurrent conditions were reported. It was reported that the patient was allergic to penicillin. On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 1 df once for osteoarthritis (batch/ lot number: 7rsl021 and expiry date: unknown). Patient had been experiencing issue on long term basis since receiving synvisc one. On unknown dates, the patient experienced severe pain and significant swelling in the knee and the patient could not bend it. The patient reported that the pain was significantly worse after the injection than prior to the injection. On (b)(6) 2017 and (b)(6) 2018, the patient consulted the health professional. At the time of report on (b)(6) 2018, the patient still had these problems. Corrective treatment: not reported for all the events outcome: not recovered for all events a product technical complaint was initiated with (b)(4). 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 is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Seriousness criteria: important medical event for device malfunction. Additional information was received on 07-feb-2018. Investigation summary results and global ptc number were added. Clinical course was updated and text was amended accordingly. Additional information was received on 24-apr-2018 from the patient. The patient's date of birth, age and height were added. The events of device malfunction, could not bend, severe pain in knee/ pain significantly worse after reaction and significant swelling in knee were added along with the details. Clinical course was updated and text was amended accordingly.
 
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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 Key7487586
MDR Text Key107384676
Report Number2246315-2018-00471
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,health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2018
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/24/2018
Was Device Evaluated by Manufacturer? No
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: 05/04/2018 Patient Sequence Number: 1
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