MAUDE Adverse Event Report: GENZYME SYNVISC HYLAN GF 20 SYNVISC HYLAN GF 20 2ML

Lot Number Q1403

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 01/11/2016

Event Type  Injury  

Event Description

Received first synvisc hylan of 20 injection on (b)(6) 2015, had major pain to point where i could not bend or walk on right knee. Missed several days of work. Second injection (b)(6) 2016, similar pain as first but not nearly as bad, 24 hrs after had minimal back pain, 48 hrs back pain was very painful, 72 hrs excruciating electric stabbing pain in lower back to point of screaming and i have high pain tolerance. Contacted (b)(6), he said that the synvisc would not be causing back pain and he had never heard of that happening. Asked if i did anything out of the norm which i answered no. I told him i read about possible side effects before calling. He told me to contact my back doctor which i don't have one. I'm supposed to get third injection on (b)(6) 2016 but now i'm scared to. Frequency: 1 per week for 3 weeks. Route: injected into knee. Reason for use: treating of arthritis in right knee. Event reappeared after reintroduced? yes.

• Brand Name: SYNVISC HYLAN GF 20
• Type of Device: SYNVISC HYLAN GF 20 2ML
• Manufacturer (Section D): GENZYME
• MDR Report Key: 5367705
• MDR Text Key: 36052783
• Report Number: MW5059333
• Device Sequence Number: 1
• Product Code: MOZ
• 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: 01/11/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/01/2017
• Device Lot Number: Q1403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage