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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 UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Arthralgia (2355); Joint Swelling (2356)
Event Date 10/01/2017
Event Type  Injury  
Event Description
This case was cross referenced with (b)(4) (same patient). This unsolicited case from united states was received on 19-oct-2017 from the patient. This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and after unknown latency, the patient cannot walk or lift her leg/ could not walk, knees blew up/extremely swollen after injection/right knee was worst/knee swelled up like two footballs that could not put on slacks/it was so swollen/right knee was way worse/totally swelled up, had pain and on a 1-10 scale, it was a thirty; experienced nausea and had trouble standing to do simple things like dishes at the sink/injection was debilitating. No relevant medical history and concomitant medications were reported. Past medications included synvisc injections in both knees (with the last one about 5 years ago). On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection (for first time) at the dose of 6 ml, once (lot number and expiration date: not reported) for advanced osteoarthritis (oa) bilaterally. On an unknown date in (b)(6) 2017, unknown latency of receiving the injection, both the knees "blew up", were warm and extremely swollen after injection. Patient had some swelling but in about 3-4 weeks, it did improved (latency: unknown). Patient also had also had nausea and the knee was also red (latency: unknown). Patient reported that her right knee was the worst and that the knee swelled up "like two footballs" and that she could not put on the slacks because it was so swollen. Patient reported that she had pain and on a 1-10 scale it was thirty (latency: unknown). Patient still could not walk or lift her leg (latency: unknown). Patient reported that the injection was "debilitating". Patient called a nurse at the doctor's office and she was told to give it time to work. Patient reported that she was even had trouble standing to do simple things like dishes at the sink (latency: unknown). Patient reported that she agreed to get the injections in the knees to avoid knee surgeries right now because she was caring for her mother who had pneumonia. Corrective treatment: not reported for all. Outcome: unknown for all the events. A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same. Seriousness criterion: permanent or significant disability for cannot walk or lift her leg/i could not walk. Pharmacovigilance comment: sanofi company comment dated 25-oct-2017: this case concerns a female patient who received synvisc one injection and has been unable to walk. Based upon the information available, the causal role of the product cannot be denied for the occurrence of event. However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection. Lack of further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors precludes the complete medical case assessment.
 
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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 Key6986440
MDR Text Key90519903
Report Number2246315-2017-00172
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 Patient
Type of Report Initial
Report Date 10/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/19/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/30/2017 Patient Sequence Number: 1
Treatment
SYNVISC(PREV.) - START UNKNOWN; SYNVISC(PREV.) - STOP
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