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

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 09/12/2018

Event Type  Injury  

Event Description

Pt admitted to hosp on (b)(6) 2018 for back operation.Name and strength : synvisc one inj 8mg/ml, dose or amount: 48mg, frequency: other, route: intra-articular, dates of use: (b)(6) 2018.

• Brand Name: SYNVISC ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 8277842
• MDR Text Key: 134367616
• Report Number: MW5083379
• 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: 01/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• 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 Outcome(s): Hospitalization
• Patient Age: 59 YR