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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ Back to Search Results
Device Problems Unstable (1667); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Pain (1994); Discomfort (2330); No Code Available (3191)
Event Type  Injury  
Event Description
Mild degree of soft tissue edema [soft tissue swelling], left knee arthroscopy [arthroscopy l knee], pain [pain nos], discomfort [discomfort nos], mild degree of lateral subluxation of the tibia and patella [subluxation knee], instability in the knee having to use a cane to walk. [joint instability], joint effusion [joint effusion], partial medial, lateral meniscectomy [knee meniscectomy], left knee surgery [knee operation], chondroplasty of the medial femoral condyle, trochlea and patella [chondroplasty], mild degenerative changes [unevaluable event], case narrative: initial information received on 29-sep-2020 regarding a solicited valid serious case from a physician, in the scope of patient support program "psp_saus. Tjo. 012". Patient id: (b)(6); country: united states; center id: unknown. Study title: (b)(6). This case involves a (b)(6) years old female patient who experienced mild degree of soft tissue edema (soft tissue swelling), left knee arthroscopy (arthroscopy), pain, discomfort, instability in the knee having to use a cane to walk (joint instability), mild degree of lateral subluxation of the tibia and patella (joint dislocation), joint effusion, partial medial, lateral meniscectomy (meniscus removal), left knee surgery (knee operation), chondroplasty of the medial femoral condyle, trochlea and patella (chondroplasty) and mild degenerative changes (unevaluable event), while she using with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc]. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate, at a dose of 10 ml weekly via subcutaneous route unknown (with an unknown batch number and expiry date) for osteoarthritis. On an unknown date, unknown latency, after initiation of suspect product, the patient had experienced mild degree of soft tissue edema (soft tissue swelling), left knee arthroscopy (arthroscopy), pain, discomfort, instability in the knee having to use a cane to walk (corrective treatment) (joint instability), mild degree of lateral subluxation of the tibia and patella (joint dislocation), joint effusion, partial medial, lateral meniscectomy (meniscus removal), left knee surgery (knee operation), chondroplasty of the medial femoral condyle, trochlea and patella (chondroplasty) and mild degenerative changes (unevaluable event). It was not reported if the patient received a corrective treatment for other events. Soft tissue swelling was assessed as medically significant as per reporter. Events outcome were unknown, at the time of reporting. Reporter causality: unassessable for all the events with respect to hylan g-f 20, sodium hyaluronate. Company causality was not reportable for all the events with respect to hylan g-f 20, sodium hyaluronate. No further information was provided.
 
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Brand NameSYNVISC
Type of DeviceMOZ
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 Key10647130
MDR Text Key213859458
Report Number2246315-2020-00141
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 health professional,study
Type of Report Initial,Followup,Followup
Report Date 05/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
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: 10/08/2020 Patient Sequence Number: 1
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