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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC. ULTRACLIP DUAL TRIGGER

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BARD PERIPHERAL VASCULAR INC. ULTRACLIP DUAL TRIGGER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ecchymosis (1818); Pain (1994)
Event Date 12/01/2014
Event Type  malfunction  
Event Description
I began noticing pain in my right breast at the location where they inserted a bard biopsy systems ultra clip trigger breast tissue marker. There is a bruise at the location and there is still pain as of (b)(6) 2017.
 
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Brand NameULTRACLIP DUAL TRIGGER
Type of DeviceULTRACLIP DUAL TRIGGER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR INC.
MDR Report Key6578172
MDR Text Key75662018
Report NumberMW5069887
Device Sequence Number1
Product Code NEU
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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