MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC INJ 8MG/ML (3X2ML); ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Burning Sensation (2146); Reaction (2414); Skin Inflammation (2443)

Event Date 08/20/2019

Event Type  Injury  

Event Description

(b)(6), admin coord from pt's md office reported that pt experienced a severe allergic reaction (burning, swollen, hot to the touch) from the synvisc one injection.

• Brand Name: SYNVISC INJ 8MG/ML (3X2ML)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 8930784
• MDR Text Key: 155556981
• Report Number: MW5089288
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009001
• UDI-Public: 58468009001
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/20/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR