MAUDE Adverse Event Report: GENZYME CORP. SYNVISC INJ 8MG/ML (3X2ML)

Lot Number 7RSP007B

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem Pain (1994)

Event Date 01/23/2018

Event Type  Injury  

Event Description

Pt called to inform us of possible contaminated synvisc 16mg/2ml pfs dispensed on (b)(6) 2017.Pt received 1st injection of synvisc for osteoarthritis of her left knee on tuesday, (b)(6) 2018 and developed throbbing pain two days later on thursday, (b)(6) 2018.On friday, (b)(6) 2018 she went to er and was given antibiotics.On tuesday, (b)(6) 2018 she went back to dr and had knee drained, was sent for ekg and other tests and admitted to surgery on thursday (b)(6) 2018.Pt came home yesterday, (b)(6) 2018, with a pic line and is in pain.Obtained lot number of remaining product from prescriber's office and advised them to call (b)(6) at (b)(6) option 1."is the product over-the-counter: no; is the product compounded: no." prescriber name: (b)(6).

• Brand Name: SYNVISC INJ 8MG/ML (3X2ML)
• Type of Device: SYNVISC INJ 8MG/ML (3X2ML)
• Manufacturer (Section D): GENZYME CORP.
• MDR Report Key: 7251082
• MDR Text Key: 99547157
• Report Number: MW5075133
• Device Sequence Number: 0
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Lot Number: 7RSP007B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR