MAUDE Adverse Event Report: MORRISVILLE VENASEAL CLOSURE SYSTEM-CE MARK; AGENT, OCCLUDING, VASCULAR, PERMANENT

Model Number SP-101

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

Patient Problems Pain (1994); Rash (2033)

Event Date 04/28/2015

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for this device did not reveal any discrepancies relevant to the reported event.Additional information has been requested, should it become available a supplemental report will be submitted.(b)(4).

Event Description

Unknown event date.Customer states that there were no problems at the time of the procedure, but post procedure months later; allergic reactions including redness on the skin, itch and some pain persisted.Treatment with nsaids has not alleviated the problem.

Manufacturer Narrative

Original mdr was sent on september 17, 2015, please reference mdr report # 3011410703-2015-00006.This is a correction to the mdr with the date of report for august 18, 2015.A review of the manufacturing records was not performed due to a lot number not being received from the user facility.

Event Description

Unknown event date.Customer states that there were no problems at the time of the procedure, but post procedure months later; allergic reactions including redness on the skin, itch and some pain persisted.Treatment with nsaids has not alleviated the problem.

Manufacturer Narrative

Additional information received confirmed that the patient received high dose steroids for 5 days of 50mg, with resolution of right limb knee reaction on (b)(6) 2015.No further care was needed.Additionally, patient details and event date were confirmed.

Manufacturer Narrative

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

• Brand Name: VENASEAL CLOSURE SYSTEM-CE MARK
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MORRISVILLE; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): MORRISVILLE; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: 15 hampshire; mansfield, MA 02480
• MDR Report Key: 5085869
• MDR Text Key: 26113203
• Report Number: 3011410703-2015-00006
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup,Followup,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SP-101
• Device Catalogue Number: SP-101
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 03/30/2016
• Supplement Dates FDA Received: 03/10/2016; 03/30/2016; 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00052 YR
• Patient Weight: 85