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

Model Number VS-402

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

Patient Problems Reaction (2414); Skin Inflammation (2443)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

As reported the patient had an allergic reaction to the venaseal adhesive.The patient's leg was bright red and worsening.Additionally, the patient was in a lot of pain with a low grade fever.The treatment was changed from keflex to clindamycin and the physician increased the nsaid dosage.The patient had a new onset of 'heartburn' which is being medically managed.This issue presented 5 days post procedure.As of (b)(6) 2016 the condition was resolved.

Manufacturer Narrative

(b)(4).

Event Description

As reported the patient had an allergic reaction to the venaseal adhesive.The patient's leg was bright red and worsening.Additionally, the patient was in a lot of pain with a low grade fever.The treatment was changed from keflex to clindamycin and the physician increased the nsaid dosage.The patient had a new onset of 'heartburn' which is being medically managed.This issue presented 5 days post procedure.As of (b)(6) 2016 the condition was resolved.

Manufacturer Narrative

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

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): COVIDIEN; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): COVIDIEN; 951 aviation parkway; morrisville NC
• Manufacturer Contact: mary haufek ; 4600 nathan lane n; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 5526797
• MDR Text Key: 41185955
• Report Number: 2183870-2016-00278
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 40492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention