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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 Edema (1820); Hypersensitivity/Allergic reaction (1907); Rash (2033); Synovitis (2094); Urticaria (2278); Arthralgia (2355); No Code Available (3191)
Event Date 11/05/2017
Event Type  Injury  
Event Description
Device malfunction [device malfunction]; synovitis both knees [synovitis of knee]; difficulty exercising [exercise capacity decreased]; stiffness [joint stiffness]; more pain than expected [knee pain]. Case narrative: this spontaneous case from united states was received on 10-may-2018 from physician. This case concerns (b)(6) patient of unknown gender who initiated treatment with synvisc one and after 2 days had more pain than expected; after an unknown latency had synovitis both knees, difficulty exercising and stiffness. A device malfunction was noted for the reported lot number. No medical history, previous medications, concomitant medications and concurrent conditions were reported. On (b)(6) 2017, patient received treatment with intra articular synvisc one injection (dose and indication: unknown) for osteoarthritis both knees (batch/ lot number: 7rsl021 and expiry date: may-2020). On (b)(6) 2017 after a latency of 2 days, patient had more pain than expected. On an unknown date in (b)(6) 2017 after an unknown latency, patient had difficulty exercising and stiffness. On an unknown date in 2017 the patient had synovitis in both knees. Corrective treatment: cortisone injections for synovitis both knees, difficulty exercising; medrol dosepak, cortisone injections for stiffness, more pain than expected. Outcome: unknown for all events. Seriousness criteria: required intervention 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 is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented.
 
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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
MDR Report Key7582985
MDR Text Key110573914
Report Number2246315-2018-00481
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 12/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/01/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? 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: 06/08/2018 Patient Sequence Number: 1
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