MAUDE Adverse Event Report: SYNVISC

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

Patient Problems Bacterial Infection (1735); Fever (1858); Swelling (2091); Chills (2191)

Event Date 12/21/2016

Event Type  Injury  

Event Description

Following an injection of synvisc into my left knee, i initially had a reaction of swelling which responded to 5 day of oral steroids.On the 5th night, i experienced increased swelling, fever of 102 degrees, chills, and went to the er on (b)(6) 2016.I was diagnosed with a bacterial infection of the knee joint and had arthroscopic surgery and spent 6 days in the hospital on iv antibiotics.This was followed by 4 weeks of iv antibiotics at home.Please investigate the material injected into my knee (the one time application of synvisc).Date the person first started taking or using the product: (b)(6) 2016.Did the problem stop after the person reduced the dose or stopped taking or using the product: no.Injection used to treat arthritis of the knee joint.

• Brand Name: SYNVISC
• Type of Device: SYNVISC
• MDR Report Key: 6256222
• MDR Text Key: 65058106
• Report Number: MW5067243
• Device Sequence Number: 1
• Product Code: MOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/11/2017

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ADVIL; ALLEGRA.; FOLIC ACID. ; OTC MEDS: TYLENOL; RX MEDS: CYMBALTA; VITAMIN B12; VITAMIN D
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 60