MAUDE Adverse Event Report: GENZYME SANOFI SYNVISC-ONE INJECTION; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 7RSL021

Device Problem Contamination (1120)

Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 11/22/2017

Event Type  Injury  

Event Description

Had an injection of synvisc-one which was from a contaminated lot.Lot #7rsl021.Experienced pain, swelling, redness, trouble walking, was later called by physician to be informed of the contamination.Had to go to the hospital for blood tests, apparently the blood tests were satisfactory.The blood tests were done a month later but had lesser levels of pain and swelling for 2 months.Did the problem stop after the person reduced the dose or stopped taking or using the product: no.Quantity: other, 1 injection.How was it taken or used: other, knee injection.Date the person first started taking or using the product: (b)(6) 2017.Why was the person using the product: pain relief for knee.

• Brand Name: SANOFI SYNVISC-ONE INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME
• MDR Report Key: 7439607
• MDR Text Key: 106000554
• Report Number: MW5076534
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 88