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 2020-03-02 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[181546753]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[181546774]
Patient received venaseal treatment of the great saphenous vein (gsv). The section treated is reported from the junction to the most distal access point below the knee. Procedure was completed without issue. It is reported the patient had a systemic allergic reaction resulting in hospital admission. Patient presented with systemic rash/hives. The patient is reported to have informed the physician post procedure of a significant reaction they experienced to medical adhesive previously. The patient has received an allergy consult and it has been recommended the patient has the vein removed. The patient remains hospitalized and is on oral steroids, benadryl, and zyrtec.
Patient Sequence No: 1, Text Type: D, B5
[182473812]
Additional information: the patient is currently in facility. The patient is expected to have the procedure to remove the vein two weeks after the implanted date. The patient was consulted on the case, but was not given any other additional treatment. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00954 |
| MDR Report Key | 9773943 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-02 |
| Date of Report | 2020-04-03 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2019-01-10 |
| 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 | VS-402 |
| Lot Number | 54221 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-02 |