MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC INJ 8MG/ML (3X2ML)

Device Problem Insufficient Information (3190)

Patient Problem Cellulitis (1768)

Event Date 08/07/2017

Event Type  Injury  

Event Description

Hospital event.Pt contacted was admitted for cellulitis in left leg.Has f/u plans in place.

• Brand Name: SYNVISC INJ 8MG/ML (3X2ML)
• Type of Device: SYNVISC INJ 8MG/ML (3X2ML)
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 6816509
• MDR Text Key: 83617924
• Report Number: MW5071766
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• 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: 52 YR