MAUDE Adverse Event Report: GENZYME SYNVISC ONE INJ 8MG/ML; HYALURONIC ACID

Catalog Number 58468009003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Pain (1994); Skin Irritation (2076); Swelling (2091); Sweating (2444)

Event Date 12/20/2016

Event Type  Injury  

Event Description

Pt called to report an adverse reaction from her synvisc-one injection given (b)(6), at mdo.The right knee and severe swelling, skin tightness, and pain radiating upper thigh.Fever and night sweating (b)(6).Mdo was aware and advised pt to go in to drain the site, but she declined and received and took 2nd prednisone which helped tremendously.She had an initial injection in (b)(6) 2016 without any reaction.

• Brand Name: SYNVISC ONE INJ 8MG/ML
• Type of Device: HYALURONIC ACID
• Manufacturer (Section D): GENZYME
• MDR Report Key: 6198167
• MDR Text Key: 63200374
• Report Number: MW5066847
• Device Sequence Number: 1
• Product Code: MOZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 58468009003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR