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

Lot Number 9RSP014A

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

Patient Problems Fatigue (1849); Headache (1880); Joint Swelling (2356); No Code Available (3191)

Event Date 07/01/2020

Event Type  Injury  

Event Description

Could barely walk [walking difficulty], sharp pain in her mid-calf area [calf pain], quiet exhausted [exhaustion], slight headache [headache], swelling in her ankle/had a lot of swelling in her knee [ankle swelling]. Case narrative: this case is linked to cases (b)(4) (multiple device; same patient). Initial information received on 27-jul-2020 regarding an unsolicited valid serious case received from united states via patient. This case involves a (b)(6) years old female patient who started treatment with hylan g-f 20, sodium hyaluronate (synvisc) and experienced sharp pain in her mid-calf area, could barely walk, quiet exhausted, slight headache and swelling in her ankle/had a lot of swelling in her knee. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient had a history of getting hylan g-f 20, sodium hyaluronate (synvisc) injections and had no issues afterwards (about 2. 5 years ago). On (b)(6) 2020, the patient started receiving hylan g-f 20, sodium hyaluronate injection weekly(dose, route and batch number unknown) for unknown indication. It was reported that before second injection, there was no fluid to drain and on (b)(6) 2020, patient received second hylan g-f 20, sodium hyaluronate injection. On an unknown date in (b)(6) 2020, after few days of receiving this second injection, patient had a slight headache, sharp pain in her mid-calf area, swelling in her ankle and the same symptoms which she had after receiving first injection that included; could barely walk (disability), she had a lot of swelling in her knee and she was quiet exhausted. It was reported, she had to use a walker to get around. Patient received third injection on (b)(6) 2020. On an unknown date in (b)(6) 2020, patient was just now able to walk and it had been 5 days since receiving the last (third) shot. Action taken: no action taken for all events. Corrective treatment: has to use a walker to get around for could barely walk. The patient outcome is reported as recovered for could barely walk; unknown for rest events.

• 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: 10349266
• MDR Text Key: 202039055
• Report Number: 2246315-2020-00085
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Lot Number: 9RSP014A
• 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: 07/31/2020 Patient Sequence Number: 1