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 2020-02-17 for VENA SEAL CLOSURE SYSTEM SP-101 manufactured by Medtronic Ireland.
[179708222]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[179708223]
Physician used a venaseal kit during bilateral treatment of the patient? S great saphenous vein (gsv). It is reported that on the right leg that there was a pruritus feeling at the puncture site and then spread to the treatment site. The patient is reported to have had a fever of 39 degrees celsius. The patient had a cold before treatment but it is unknown if the fever is related. The patient visited a hospital the day after treatment and visited a different hospital one day later. The patient also went recreational fishing which seemed to make the cold worse. The patient underwent a stripping procedure on the right gsv due to the temperature and loxonin was prescribed. No further patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[188636806]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00745 |
| MDR Report Key | 9716711 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-17 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-06-05 |
| Date Added to Maude | 2020-02-17 |
| 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 | 2020-02-17 |
| Catalog Number | SP-101 |
| Lot Number | 55952 |
| 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 | 2020-02-17 |