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GENZYME SYNVISC-ONE Back to Search Results
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.
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Brand Name
Type of Device
Manufacturer (Section D)
MDR Report Key7209040
MDR Text Key97985781
Report NumberMW5074689
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received01/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age75 YR
Patient Weight77