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

Lot Number UNKNOWN

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/01/2021

Event Type  Injury  

Event Description

Not been able to do anything around her home [impaired work ability]. Blood pressure has been elevated [blood pressure high]. Hardly bare weight on her right leg [difficulty in standing]. She can barely walk [difficulty in walking]. Leg has felt stiff [stiffness]. Weakness [weakness]. Her feet have blackened in color [skin discoloration]. Tiredness [tiredness]. Balance is off [balance disorder]. Skin appears scaly [skin scaly]. Right leg is swollen up like a balloon [unilateral leg swelling]. Fluid build in her leg, knee, ankle, and foot; "so severe [leg oedema]. She feels dizzy [dizziness]. Headaches [headache]. After the first injection, stating it was swelling [injection site swelling]. After the first injection, stating it was painful [injection site pain]. Knee did appear reddish in color [injection site erythema]. Had ankle tenderness [joint tenderness]. Fluid build in her leg, knee, ankle, and foot; "so severe [joint effusion]. Case narrative: initial information received on 11-oct-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from united states. This case involves a (b)(6) female patient who experienced not been able to do anything around her home, blood pressure has been elevated, hardly bare weight on her right leg, she can barely walk, leg has felt stiff, weakness, her feet have blackened in color, tiredness, balance is off, skin appears scaly, right leg is swollen up like a balloon, fluid build in her leg, knee, ankle, and foot; "so severe, she feels dizzy, headaches, after the first injection, stating it was swelling, after the first injection, stating it was painful, knee did appear reddish in color, had ankle tenderness and fluid build in her leg, knee, ankle, and foot; "so severe 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. On the unknown date of (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, batch number, route, frequency: unknown) for osteoarthritis. On the unknown date of (b)(6) 2021, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced that she was not been able to do anything around her home (impaired work ability) (disability), blood pressure has been elevated (hypertension) 170/95, 165/95, hardly bare weight on her right leg (dysstasia), she could barely walk (gait disturbance), leg has felt stiff (musculoskeletal stiffness), weakness (asthenia), her feet have blackened in color (skin discoloration), tiredness (fatigue), balance was off (balance disorder), skin appears scaly (skin exfoliation), right leg was swollen up like a balloon (peripheral swelling), fluid build in her leg, knee, ankle, and foot; "so severe (joint effusion) (oedema peripheral), she felt dizzy (dizziness), headaches (headache), after the first injection, stating it was swelling (injection site swelling) and it was painful, knee did appear reddish in color, had ankle tenderness (injection site erythema) (arthralgia). She had been elevating her legs. She has not used ice. She contacted hcp who did injection but reports they felt the symptoms were not related to the injection. Action taken: unknown for all the events. Corrective treatment: not reported for all the events. Outcome: unknown for all the events.

• Brand Name: SYNVISC ONE
• 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: 12643818
• MDR Text Key: 281910314
• Report Number: 2246315-2021-00165
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 10/16/2021 Patient Sequence Number: 1