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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During procedure, venaseal occluding device was used during procedure in both legs and had a really bad allergic reaction of an itching rash on feet, in back of knees, arms, hands and back.Patient was put on famotuidine, zertek, methlpred and montelukast, these medications were reported to have helped the itchiness, but the rash remained.No further injury reported.

Manufacturer Narrative

Additional information: physician has been contacted and reported that the adverse events are unlikely to be venaseal related.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): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9900379
• MDR Text Key: 185917730
• Report Number: 9612164-2020-01408
• 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,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 05/20/2020
• Supplement Dates FDA Received: 05/29/2020
• 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