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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Bacterial Infection (1735); Hypersensitivity/Allergic reaction (1907)

Event Date 10/01/2015

Event Type  Injury  

Event Description

Cellulitis [cellulitis]. Septic arthritis [septic arthritis]. Allergic reaction to synvisc [allergic reaction]. Case narrative: initial information was received on 08-dec-2020 regarding a solicited valid serious case from a physician, in the scope of market research program (b)(4). (b)(6). This case involves a (b)(6) years old female patient who experienced cellulitis, septic arthritis and allergic reaction to synvisc, after with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc). The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On an unknown date, the patient started using synvisc (hylan g-f 20, sodium hyaluronate) (with an unknown batch number, dose, frequency, route and indication). Information on batch number was requested. On an unknown date in (b)(6) 2015, after unknown latency, the patient experienced moderate septic arthritis (arthritis bacterial), moderate cellulitis and moderate allergic reaction to synvisc (hypersensitivity). The patient was hospitalized for all the reported events. The events of cellulitis and septic arthritis were assessed as medically significant. The patient received unspecified antibiotics as corrective treatment for the events. Final diagnosis was allergic reaction to synvisc, septic arthritis and cellulitis. Action taken: unknown for all the events. Corrective treatment: unspecified antibiotics for all the events. The patient outcome is reported as unknown for all the events. Reporter causality: unassessable for all the events. Company causality: reportable for all the events. A product technical complaint (ptc) was initiated, and results were pending for the same.

• Brand Name: SYNVISC
• Type of Device: MOZ
• 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 Key: 11018524
• MDR Text Key: 226771419
• Report Number: 2246315-2020-00169
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/16/2020 Patient Sequence Number: 1