MAUDE Adverse Event Report: SANOFI GENZYME SYNVISC-ONE LOT #7RSL021

Lot Number 7RSL021

Device Problems Nonstandard Device (1420); Contamination of Device Ingredient or Reagent (2901)

Patient Problems Abscess (1690); Muscle Weakness (1967); Pain (1994); Joint Swelling (2356)

Event Date 12/12/2017

Event Type  Injury  

Event Description

Contaminated synvisc one.On (b)(6) 2017 at approximately 1pm, i received a synvisc-one injection in both my right and left knees.The injections were given under the direction of dr.(b)(6) at his office at (b)(6).The actual shots were given by dr.(b)(6).The synvisc-one lot # was 7rsl021.The night of (b)(6), i did not sleep at all due to pain in my right knee.My whole right leg was weak, and the muscle above the right knee was very painful.The knee pain was both an on-going pain with increasing pressure as well as a stabbing pain at times.My right knee was extremely swollen.On the morning of (b)(6) at 8am, i called the dr.Office to describe my symptoms and pain.I was told the pa would be in by 11am and that she would call me.At approx 11 am the pa called me back and prescribed ice and aleve.At approx.12:30 pm on (b)(6) the pa called me back and told to come into the dr.Office asap as the synvisc-one received was a contaminated medicine lot and was recalled.On (b)(6) at approx 2:30 pm my right knee was drained and 2 vials of liquid removed of a yellow pus nature was removed by the pa.The pain i experienced during this knee draining was excruciating and extremely painful.I was told this liquid would be sent for a culture growth.I was told to come back to the office on (b)(6).During the time period of (b)(6), i continued to have severe continuous pain that prevented me from sleeping and i was (and am still to this day) unable to perform my planned work and life activities.On (b)(6) 2017 at 11 am i saw dr.(b)(6) in the (b)(6) office.Dr.(b)(6) drained my knee for the second time.This was also to be sent for a culture growth.As of today (b)(6) 2017, i continue to have severe continuous pain that prevents me from sleeping a full night and my right knee is still swollen.My knee is significantly worse than when i went for the injection on (b)(6) 2017.I am on the schedule to see dr.(b)(6) again on (b)(6) 2018.Is the product compounded: yes.Quantity: other - 2 injections.Frequency: as needed.How was it taken or used: subcutaneous.Date the person first started taking or using the product: (b)(6) 2017.Date the person stopped taking or using the product: (b)(6) 2017.Why was the person using the product: product taken to alleviate pain in both right and left knees.

• Brand Name: SYNVISC-ONE LOT #7RSL021
• Type of Device: SYNVISC-ONE LOT #7RSL021
• Manufacturer (Section D): SANOFI GENZYME
• MDR Report Key: 7154462
• MDR Text Key: 96212378
• Report Number: MW5074293
• 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: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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; Disability
• Patient Age: 61 YR
• Patient Weight: 106