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 2020-03-19 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[184056233]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184056254]
Physician treated patient with venaseal. Patient had the length of the great saphenous vein (gsv) treated. Ifu was followed and no issues were noted during procedure. During follow-up the patients gsv was reported to have closed but the patient reported having pain, redness, and itching throughout the treated segment. Patient was prescribed nsaids, benadryl, and a medrol dosepack. Patient was further prescribed a large dose of steroids and antibiotics. Patient? S symptoms are still present
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01229 |
| MDR Report Key | 9852865 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2019-09-19 |
| Date Added to Maude | 2020-03-19 |
| 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 Country | IE |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | MEDTRONIC IRELAND |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Country | IE |
| 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 | 2020-03-19 |
| Model Number | VS-402 |
| Catalog Number | VS-402 |
| Lot Number | 56951 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC IRELAND |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY IE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-19 |