MAUDE Adverse Event Report: GENZYME SYNVISC-ONE

Lot Number 7RSL021

Device Problems Contamination (1120); Nonstandard Device (1420)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Tissue Damage (2104); Discomfort (2330)

Event Date 12/04/2017

Event Type  Injury  

Event Description

Reporter stated that she had surgery back in (b)(6) for a torn meniscus which led to fluid accumulation and swelling.Pt said she had fluid extraction thrice and two steroid shots.On (b)(6) 2017, the dr placed cushion (injection) due to pain and fluid accumulation.According to pt, upon stepping off of the table after receiving the injection, she stumbled and her knees were unable to support her weight.Reporter says on (b)(6) 2017, she decided to visit her dr due to persistent pain.During that visit, another fluid extraction was done.Reporter says she was then placed on antibiotic (bactrim) due to infection.Then on tuesday of (b)(6) 2017, reporter states that she was contacted by the dr's nurse who informed her that the injection she received on (b)(6) 2017 is part of a batch that has been recalled by fda for contamination.Reporter says the mfr of this device (injection) owes her for the misery and discomfort that she has and continues to live with.Reporter says she has lost the ability to do anything even taking care of herself.

• Brand Name: SYNVISC-ONE
• Type of Device: SYNVISC-ONE
• Manufacturer (Section D): GENZYME
• MDR Report Key: 7209040
• MDR Text Key: 97985781
• Report Number: MW5074689
• 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: 01/19/2018

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 Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 77