MAUDE Adverse Event Report: GENZYME CORP. SYNVISC INJ 8MG/ML (3X2 ML); ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 12/07/2018

Event Type  Injury  

Event Description

The pt experienced pain and stiffness in the knee lasting for a week or more after each injection of synvisc.The patient¿s side effects are so bad, she will not be completing the third dose of synvisc.The patient is convinced the order of medication she received is linked to the synvisc-one recall from 2017.Dates of use: from (b)(6) 2018; is the product compounded? no; is the product over-the-counter? no.

• Brand Name: SYNVISC INJ 8MG/ML (3X2 ML)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORP.
• MDR Report Key: 8208370
• MDR Text Key: 131998990
• Report Number: MW5082712
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009001
• UDI-Public: 58468009001
• Combination Product (y/n): N
• 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: 12/21/2018

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: 12/31/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR