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 |