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Device Problem Patient-Device Incompatibility (2682)
Patient Problems Edema (1820); Swelling (2091); Thrombosis (2100); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). On 28 november 2011, the fda granted the permission for the manufacturer fidia (b)(4). To submit a single mdr for adverse events that involve medical devices manufactured by fidia (b)(4). And imported into the usa by (b)(4). As a consequence, fidia (b)(4). (the manufacturer) is submitting this report even on behalf of (b)(4) (the importer). The present mdr report satisfies the reporting obligations for both companies. The literature case comes from the literature monitoring screening performed by the company. The patient after the injection of a product containing hyaluronate sodium as active substance experienced: deep vein thrombosis, peripheral swelling, sensation of heat, tenderness and pretibial edema. The case has been deemed as serious by the reporter due to hospitalization. The case has been deemed as serious/unexpected. The causality relationship has been evaluated as probable by the company. No new signal alert has been detected. The paper reference is: altinbas ö. , çomakli h. Deep vein thrombosis after sodium hyaluronate injection to knee joint: a case report. J. Clin. Anal. Med. 2018 9:5 (466-468).
Event Description
This case was detected in the medical literature from altinbas ö. , çomakli h. Deep vein thrombosis after sodium hyaluronate injection to knee joint: a case report. J. Clin. Anal. Med. 2018 9:5 (466-468). This spontaneous case was reported in the medical literature by a physician from (b)(6). A (b)(6) -year-old man was admitted to our clinic with complaints of lower right extremity pain, swelling, and difficulty while walking. These complaints had started 15 days previously. The patient had a history of sodium hyaluronate injection (20 mg/2 ml) to the right knee joint due to osteoarthritic joint pain one month before. Before the injection, right lower extremity venous doppler usg was performed for deep vein thrombosis but no thrombosis was detected. His symptoms did not diminish despite the nonsteroidal anti-inflammatory treatment. He reported hypertension and chronic obstructive pulmonary disease as additional diseases. After informed consent, the patient was included in this study. Physical examination of the patient's right leg revealed swelling of the whole extremity, increased heat, tenderness, and pretibial mild edema. Peripheral pulses were palpable and there were no signs of ischemia. His thigh and calf were painful during palpation and homan's sign was positive. Laboratory findings included complete blood count, c-reactive protein, and biochemistry results related to kidney and liver functions and these results were normal. But d-dimer was 3. 9 mg/l, higher than a normal value. The thrombophilia panel results, including factor v leiden, fii prothrombin, mthfr c 677t, and mthfr a 1298 c, were normal. In addition, anti-cardiolipin and anti-phospho-lipid antibodies were negative; protein c, protein s, and antithrombin were normal. Right lower extremity venous doppler usg indicated acute-subacute thrombus material in the common, superficial, and deep femoral veins and in the popliteal vein. There was no flow or response to the compression. Low molecular weight heparin (lmwh) (enoxaparin sodium) 8000 anti xa/0. 8 ml twice a day proper to his weight, upper knee compression socks, and elevation of the extremity were started as the initial therapy. Warfarin sodium, 5 mg a day, was added to the therapy in the third day and lmwh was stopped when his international normalised ratio (inr) was above 2. His symptoms diminished and he was discharged from the hospital one week after admission with the suggestion of monthly inr controls. The third month lower right extremity venous doppler usg revealed recanalized flow in the venous structures mentioned above but there was still thrombus material on the vein walls compatible with the chronic period. His inr value was proper for his treatment (between 2-3) so warfarin sodium treatment was continued for another three months. Sixth month venous doppler usg revealed complete patency in the common, superficial, and deep femoral veins and in the popliteal vein and there were no thrombus materials. But irregularity on venous wall structures was reported. Warfarin sodium treatment was stopped and treatment continued with 100 mg per day of acetylsalicylic acid. After six months of this therapy there was no repetition of symptoms or thrombus, and treatment was stopped at the end of one year.
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Manufacturer (Section D)
via ponte della fabbrica, 3/a
abano terme, padua 35031
IT 35031
Manufacturer (Section G)
via ponte della fabbrica, 3/a
abano terme, padua 35031
IT 35031
Manufacturer Contact
giuseppe di sante
via ponte della fabbrica, 3/a
abano terme, padua 35031
IT   35031
MDR Report Key7543860
MDR Text Key109355512
Report Number9610200-2018-00006
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/11/2018
Event Location No Information
Date Manufacturer Received05/07/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/25/2018 Patient Sequence Number: 1