MAUDE Adverse Event Report: SAPHEON INC VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 05/01/2015

Event Type  Injury  

Manufacturer Narrative

Month and year only valid.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a patient had his left gsv treated with venaseal.Two weeks after the procedure the patient developed generalized urticaria (hives), sparing the face.He was treated initially on steroids which were then tapered off and began taking an antihistamine (cetirizine) which suppressed the symptoms.At this time, if the patient stops cetirizine the hives return.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): SAPHEON INC; 951 aviation pkwy ste 900; morrisville NC 27560
• Manufacturer (Section G): SAPHEON INC; 951 aviation pkwy ste 900; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6646008
• MDR Text Key: 77702316
• Report Number: 3011410703-2017-00251
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention