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 2016-03-03 for VENA SEAL CLOSURE SYSTEM SP-101 manufactured by Sapheon/medtronic.
[39532469]
(b)(4).? A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[39532470]
It was reported the patient underwent venaseal treatment of left long saphenous vein. No problems at the time of the procedure, but 11 days later, patient has contacted the doctor complaining of redness on the skin, itch and some pain. The sample was not available for return by the end user. The mild inflammation responded well to oral and topical anti-inflammatory which is consistent with non-specific mild inflammation of the cutaneous and subcutaneous tissue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011410703-2016-00002 |
| MDR Report Key | 5476092 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-03-03 |
| Date of Report | 2015-04-07 |
| Date of Event | 2015-03-27 |
| Date Mfgr Received | 2015-04-07 |
| Device Manufacturer Date | 2014-07-28 |
| Date Added to Maude | 2016-03-03 |
| 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 | MARY HAUFEK |
| Manufacturer Street | 951 AVIATION PKWY SUITE 900 |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 7633987000 |
| Manufacturer G1 | SAPHEON/MEDTRONIC |
| Manufacturer Street | 951 AVIATION PKWY SUITE 900 |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENA SEAL CLOSURE SYSTEM |
| Generic Name | CLOSURE, WOUND, ADHESIVE |
| Product Code | MGO |
| Date Received | 2016-03-03 |
| Model Number | SP-101 |
| Catalog Number | SP-101 |
| Lot Number | 37621 |
| Device Expiration Date | 2016-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAPHEON/MEDTRONIC |
| Manufacturer Address | 951 AVIATION PKWY SUITE 900 MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-03 |