MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-24 for VWING VASCULAR NEEDLE GUIDE 00144 manufactured by Vital Access Corp..
[41029625]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[41029626]
Implanting surgeon removed a vwing device due to an apparent allergic reaction. No overt complications identified. The patient tolerated the procedure well. Reporting nurse identified that the patient's arm has returned to normal following device removal. No further symptoms of redness or itching.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009273792-2016-00004 |
| MDR Report Key | 5522399 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-24 |
| Date of Report | 2016-03-15 |
| Date of Event | 2016-01-19 |
| Date Mfgr Received | 2016-02-15 |
| Device Manufacturer Date | 2015-07-02 |
| Date Added to Maude | 2016-03-24 |
| 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 | MARK CRAWFORD |
| Manufacturer Street | 448 E. WINCHESTER ST. SUITE 250 |
| Manufacturer City | SALT LAKE CITY UT 84107 |
| Manufacturer Country | US |
| Manufacturer Postal | 84107 |
| Manufacturer Phone | 8014339390 |
| Manufacturer G1 | VITAL ACCESS CORP. |
| Manufacturer Street | 448 E. WINCHESTER ST. SUITE 250 |
| Manufacturer City | SALT LAKE CITY UT 84107 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84107 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VWING VASCULAR NEEDLE GUIDE |
| Generic Name | VWING |
| Product Code | PFH |
| Date Received | 2016-03-24 |
| Model Number | 00144 |
| Lot Number | 15-0033 |
| Device Expiration Date | 2015-03-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VITAL ACCESS CORP. |
| Manufacturer Address | 448 E. WINCHESTER ST. SUITE 250 SALT LAKE CITY UT 84107 US 84107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-03-24 |