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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID Back to Search Results
Lot Number 7RSL021
Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Pain (1994); Swelling (2091); Reaction, Injection Site (2442)
Event Type  malfunction  
Event Description
This case is cross referenced with (b)(4) (same reporter). This unsolicited case from united states was received on 20-feb-2018 from the healthcare professional. This case concerns a (b)(6) female patient who received treatment with synvisc one and later after unknown latency had a reaction to injection. Also, device malfunction was identified for the reported lot number. Patient was allergic to sulfamethoxazole/trimethoprim (bactrim), codeine and hydrocodone bitartrate/ paracetamol (vicodin). No concurrent condition was provided. Patient's concomitant medication included calcium, diazepam, estrogens, metformin hydrochloride (metformin) and levothyroxine sodium (levothyroxine). On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once (dose and indication: unknown) (batch/lot number: 7rsl021; expiry date: may-2020). On an unknown date, after unknown latency, the patient was hospitalized due to reaction to injection. It was reported that patient had injection pain and swelling. On (b)(6) 2018, the c reactive protein was found to be decreased and cbc as abnormal, fungus culture and anerobic culture was negative. Corrective treatment: not reported outcome: not recovered for both the events. Reporter causality: related with both events. A pharmaceutical 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 is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Seriousness criteria: hospitalization for had a reaction to injection and device malfunction.
 
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Brand NameSYNVISC ONE
Type of DeviceINTRA-ARTICULAR HYALURONIC ACID
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleadantview terrace
ridgefield NJ 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive
55b-220a
bridgewater, NJ 08807
9089817289
MDR Report Key7327036
MDR Text Key102337808
Report Number2246315-2018-00365
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 health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 02/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2018
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/09/2018 Patient Sequence Number: 1
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