MAUDE Adverse Event Report: GENZYME SYNVISC (3X2ML PREFILLED SYR); ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Urticaria (2278); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Spontaneous: (b)(6), precertification representative at md office, stated pt had a bad reaction to the synvisc (rash/swelling/hives).Md will be switching pt to euflexxa.No further information was provided.Reported to (b)(6) by health professional.

• Brand Name: SYNVISC (3X2ML PREFILLED SYR)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME
• MDR Report Key: 12475229
• MDR Text Key: 271803122
• Report Number: MW5103944
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2021
• Patient Sequence Number: 1