MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Nausea (1970); Numbness (2415); Swelling/ Edema (4577)

Event Date 04/26/2022

Event Type  Injury  

Event Description

Received synvisc in left knee the morning of (b)(6) 2022.That evening entire leg began to swell and numbness occurred from toes and pad left foot and traveled on left lateral aspect into left hip.Symptoms continued to intensify.I also experienced queasy stomach, pins and needle sensation in foot into leg.On (b)(6) i was no longer able to wear a shoe on left foot due to swelling.Edema was +2 pitting edema in foot into calf.I was afebrile but was concerned about redness on left lateral and medial aspect of ankle.I was unable to stand on left leg due to pain and awakened several times during the night due to pain.I was unable to reach provider who injected synvisc, therefore scheduled appointment with pa at pcp office.A nurse from orthopedic provider called afterwards.I explained symptoms to him and told him i had scheduled pa appointment.Pa was unfamiliar with synvisc.She wrapped ace wrap around foot and leg, advised elevating and icing leg.Fda safety report id# (b)(4).

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 14282559
• MDR Text Key: 290793110
• Report Number: MW5109493
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other