MAUDE Adverse Event Report: SYNVISC INJECTION; HYALURONIC INJECTION

Device Problem Insufficient Information (3190)

Patient Problems Arthritis (1723); Hemorrhage/Bleeding (1888); Discomfort (2330)

Event Date 02/01/2014

Event Type  Injury  

Event Description

(b)(6) had 3 injection of (hylan - generic name) in right knee.After third injection, he started complaining about hemorrhoids (external - slight bleeding), lots of discomfort.Started using hemorrhoid cream.Eventually discomfort went way.On list of side effects, hemorrhoids was one of them.Notified dr (b)(6) office and (b)(6) and fda.Lubricant injection for knee) administered by specialist in bone and joint problems.(three injections) 1 a week for 3 weeks.First started taking or using the product: (b)(6) 2014.Stopped taking or using the product: (b)(6) 2014.Arthritis in right knee.This was prepared for you by (b)(6).Hemorrhoids with slight bleeding and discomfort.Hylan provided by (b)(6).

• Brand Name: SYNVISC INJECTION
• Type of Device: HYALURONIC INJECTION
• MDR Report Key: 3717440
• MDR Text Key: 19197744
• Report Number: MW5035378
• 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: Other
• Type of Report: Initial
• Report Date: 02/23/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Treatment: ZOLPIDEM 10MG; ARTANE 2MG; SIMVASTATIN 20MG; CLONAZEPAM 0.5; AMANTADINE 100MG; SINEMET 20/100; ROVICET 5MG, 4 X DAY AS NEEDED
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 102