MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-02 for VENA SEAL CLOSURE SYSTEM SP-101 manufactured by Medtronic Ireland.
[181548363]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[181548364]
It is reported out of 1365 patients and 2595 treated veins, 19 patients have had an lymph fistula (0. 73%). In 19 cases, the fistula was opened and cleaned then they healed without complications in all described cases. Physician reported event as not a complication but just as a side effect which occurs with every surgery treatment in a ratio of 2-3 % and it is not deemed to be related to venaseal.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9612164-2020-00953 |
MDR Report Key | 9773860 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2020-03-02 |
Date of Report | 2020-03-30 |
Date Mfgr Received | 2020-03-11 |
Date Added to Maude | 2020-03-02 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | TONI O'DOHERTY |
Manufacturer Street | PARKMORE BUSINESS PARK WEST |
Manufacturer City | GALWAY |
Manufacturer Phone | 091708734 |
Manufacturer G1 | MEDTRONIC IRELAND |
Manufacturer Street | PARKMORE BUSINESS PARK WEST |
Manufacturer City | GALWAY |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VENA SEAL CLOSURE SYSTEM |
Generic Name | AGENT, OCCLUDING, VASCULAR, PERMANENT |
Product Code | PJQ |
Date Received | 2020-03-02 |
Catalog Number | SP-101 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDTRONIC IRELAND |
Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2020-03-02 |