MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-26 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[172803667]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[172803668]
Patient successfully treated with venaseal with favorable outcome. 3 weeks later patient returned for second venaseal treatment of great saphenous vein (gsv). 12 days post second venaseal treatment, the patient returned complaining of a full body rash. The patient was given medrol and the symptoms are reported to have cleared up. No additional treatment required.
Patient Sequence No: 1, Text Type: D, B5
[188148544]
Aware date should be 13 mar 2020. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188148545]
Patient successfully treated with venaseal with favorable outcome. 3 weeks later patient returned for second venaseal treatment of great saphenous vein (gsv). 12 days post second venaseal treatment, the patient returned complaining of a full body rash. The patient was given medrol and the symptoms are reported to have cleared up. No additional treatment required. No further injury reported.
Patient Sequence No: 1, Text Type: D, B5
[188148546]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2019-05298 |
| MDR Report Key | 9519342 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-26 |
| Date of Report | 2020-03-18 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2019-12-26 |
| 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 | 2019-12-26 |
| Catalog Number | VS-402 |
| Lot Number | UNK |
| 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 | 2019-12-26 |