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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Vomiting (2144); Dizziness (2194); Arthralgia (2355); Joint Swelling (2356); Malaise (2359); No Code Available (3191)
Event Date 09/10/2019
Event Type  Injury  
Event Description
Difficulty in going down the stairs [walking difficulty]. Pain in her right knee [aching (r) knee]. Joint effusion/swollen where she was punctured, refers worsening [joint effusion]. Swelling of her right knee/swollen where she was punctured, refers worsening [swelling of r knee]. Blood test was performed, which resulted high cholesterol (225 does not refer units) [cholesterol blood increased]. Discomfort in the right knee [discomfort in joints]. Vomiting [vomiting]. Malaise [malaise]. Dizziness [dizziness]. Nausea [nausea]. Synvisc one given for chondromalacia [device use in unapproved indication]. Assuming she had a bad infiltration [unevaluable event]. Case narrative: based on additional information received on 10-oct-2019, this case initially assessed as non-serious was updated to serious as intervention was required for events of swelling of her right knee/swollen where she was punctured, refers worsening, joint effusion/swollen where she was punctured, refers worsening, pain in her right knee, difficulty in going down the stairs. This case is linked to case (b)(4) (multiple devices). Initial information received on 23-sep-2019 from (b)(6) regarding an unsolicited valid serious case received from a physician by sales representative. This case involves a (b)(6) female patient who experienced difficulty in going down the stairs, vomiting, malaise, nausea, pain in her right knee, dizziness, joint effusion/swollen where she was punctured, refers worsening, swelling of her right knee/swollen where she was punctured, refers worsening, blood test was performed, which resulted high cholesterol (225 does not refer units), and discomfort in the right knee (latency: few days for all events) assuming she had a bad infiltration, synvisc one given for chondromalacia (latency: same day), while she was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had allergy from hyoscine. Patient denied any pathology. Concomitant medications include calcium. Patient denied allergies to hyaluronic acid, referred that she applied every day in facial cream on the face without discomfort. On (b)(6) 2019, patient was fine, she could dance without problems. On (b)(6) 2019 or (b)(6) 2019 (patient does not remember well), few weeks ago, the patient started using synvisc one (hylan g-f 20, sodium hyaluronate), formulation unknown via intra-articular route, at dose of 6 ml once (lot - unknown) in right knee for grade 2 chondromalacia. The information on lot number was requested. The patient was at rest for 3 days without any discomfort after synvisc one application. Patient referred that she complied with all the indications of her treating physician, after synvisc application. The patient assumed she had a bad infiltration (same day after starting use of hylan g-f 20 sodium hyaluronate), the patient decided to perform the second infiltration with other physician. On (b)(6) 2019, few days later, the patient had joint effusion and presented with swelling of her right knee, pain in her right knee, swollen where she was punctured, refers worsening, difficulty in going down the stairs, presents nausea, dizziness, malaise and vomiting (intervention was required for difficulty in going down the stairs, pain in her right knee, joint effusion, swelling of her right knee/swollen where she was punctured, refers worsening and discomfort in the right knee was). The patient was recovered from dizziness, malaise, nausea, and vomiting on the same day. On same day, after few days of synvisc one administration, a blood test was performed, which resulted high cholesterol (225 does not refer units). It was reported that the patient had improvement in the left knee (the knee that did not receive synvisc), but discomfort in the right knee on an unknown date in 2019 (latency: unknown). On (b)(6) 2019, the patient recovered from swelling and right knee pain. On (b)(6) 2019, patient recovered from joint effusion. It was reported that in 1 month the patient will undergo high cholesterol control. Reportedly, the action taken with the medicine was none. Action taken- not applicable for all events. Corrective treatment- atorvastatin for high cholesterol; corticosteroid (no referred name) im, ice, ointment, no referred name and spray (no referred name to deflate) for swelling of her right knee/swollen where she was punctured, refers worsening, joint effusion/swollen where she was punctured, refers worsening, pain in her right knee, difficulty in going down the stairs; not reported for rest all events. The patient outcome is reported as recovered / resolved for joint effusion/swollen where she was punctured, refers worsening, nausea, dizziness, vomiting, malaise, swelling of her right knee/swollen where she was punctured, refers worsening, pain in her right knee; unknown for assuming she had a bad infiltration, difficulty in going down the stairs, blood test was performed, which resulted high cholesterol (225 does not refer units), discomfort in the right knee; not applicable for synvisc one given for chondromalacia. A product technical complaint was initiated and results were pending for the same. Reporter causality: the causality assessment by the reporter was associated for vomiting, malaise, nausea, pain in her right knee, dizziness, joint effusion/swollen where she was punctured, refers worsening, swelling of her right knee/swollen where she was punctured, refers worsening, blood test was performed, which resulted high cholesterol (225 does not refer units). Additional information was received on 10-oct-2019 from healthcare professional. Event added for difficulty in going down the stairs, vomiting, malaise, nausea, pain in her right knee, dizziness, joint effusion/swollen where she was punctured, refers worsening, swelling of her right knee/swollen where she was punctured, refers worsening, blood test was performed, which resulted high cholesterol (225 does not refer units), synvisc one for chondromalacia and discomfort in the right knee. Medical history and concomitant medications added. Clinical course was updated, and text amended accordingly.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key9225926
MDR Text Key163552218
Report Number2246315-2019-00265
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2019
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
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: 10/23/2019 Patient Sequence Number: 1
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