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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME SYNVISC-ONE
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GENZYME SYNVISC-ONE Back to Search Results
Lot Number 7RSL021
Medical Device Problem Codes Contamination (1120); Nonstandard Device (1420)
Health Effect - Clinical Codes Unspecified Infection (1930); Pain (1994); Swelling (2091); Tissue Damage (2104); Discomfort (2330)
Date of Event 12/04/2017
Type of Reportable Event Serious Injury
Event or Problem 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
SYNVISC-ONE
Common Device Name
SYNVISC-ONE
Manufacturer (Section D)
GENZYME
MDR Report Key7209040
Report NumberMW5074689
Device Sequence Number951308
Product Code MOZ
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 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
Operator of Device No Information
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/19/2018
Patient Sequence Number1
Patient Age75 YR
Patient Weight77
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