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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VITAL ACCESS CORP. VWING VASCULAR NEEDLE GUIDE
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VITAL ACCESS CORP. VWING VASCULAR NEEDLE GUIDE Back to Search Results
Model Number 00144
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Date 01/19/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
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.
 
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Brand Name
VWING VASCULAR NEEDLE GUIDE
Type of Device
VWING
Manufacturer (Section D)
VITAL ACCESS CORP.
448 e. winchester st.
suite 250
salt lake city UT 84107
Manufacturer (Section G)
VITAL ACCESS CORP.
448 e. winchester st.
suite 250
salt lake city UT 84107
Manufacturer Contact
mark crawford
448 e. winchester st.
suite 250
salt lake city, UT 84107
8014339390
MDR Report Key5522399
MDR Text Key41029625
Report Number3009273792-2016-00004
Device Sequence Number1
Product Code PFH
UDI-Device Identifier08199260101458
UDI-Public8199260101458
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date03/31/2015
Device Model Number00144
Device Lot Number15-0033
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
AV FISTULA NEEDLES
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age53 YR
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