MAUDE Adverse Event Report: SANOFI-AVENTIS U. S., LLC / GENZYME SYNVISC ONE; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 7RSL049

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Purulent Discharge (1812); Pain (1994); Sepsis (2067)

Event Date 06/14/2018

Event Type  Injury  

Event Description

Pt received synvisc-one injection on (b)(6) 2018 for osteoarthritis.Pt returned to the hospital two days later ((b)(6) 2018) with significant knee pain.Pt was diagnosed with septic knee and had purulent drainage aspirated from knee.Pt was hospitalized after r.Knee washout.Pt continues to be in the hospital during this report (b)(6) 2018.Lot # 7rsl049, exp: 10/31/2020 for synvisc one.Event abated after use stopped or dose reduced: yes.Dose or amount: 1 an - as necessary, frequency: as needed, route: intra-articular.Strength: 1 injection an - as necessary.Therapy start date: (b)(6) 2018; therapy end date: (b)(6) 2018.

• Brand Name: SYNVISC ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SANOFI-AVENTIS U. S., LLC / GENZYME
• MDR Report Key: 7628848
• MDR Text Key: 112219415
• Report Number: MW5077991
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2018

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
• Device Expiration Date: 10/31/2020
• Device Lot Number: 7RSL049
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR