InjuryPFH
VWING VASCULAR NEEDLE GUIDE
Received Mar 24, 2016 · Event occurred Jan 19, 2016
Report 3009273792-2016-00004 · MDR key 5522399
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
53 YR
- Reaction
- Reaction
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
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.