MAUDE Adverse Event Report: GENZYME CORP. SYNVISC-ONE INJ 8MG/ML; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Date 11/21/2018

Event Type  Injury  

Event Description

Pt had her injection of synvisc one for her right knee on friday (b)(6) 2018.She followed all the post-op instruction in respect to rest and not putting any weight on the affected knee but now she is reporting that the knee is very painful and she described the pain is severe.She said the injection site looks normal.Also there is no swelling at the injection site or around her knee and her knee looks normal.She stated that past the first 48 hours after the injection, she hasn't seen any improvement and it feels like it is getting worse.Route: intra-articular.Dates of use: (b)(6) 2018.Is the product compounded? no; is the product over-the-counter? no.

• Brand Name: SYNVISC-ONE INJ 8MG/ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORP.
• MDR Report Key: 8138682
• MDR Text Key: 129754610
• Report Number: MW5081886
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009003
• UDI-Public: 58468009003
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR