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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVICOR MAMMOMARK BREAST TISSUE MARKER CLIP

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DEVICOR MAMMOMARK BREAST TISSUE MARKER CLIP Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Date 03/12/2012
Event Type  Injury  
Event Description
A routine screening resulting biopsy marker clip asa risk recalls possible rare reaction.
 
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Brand NameMAMMOMARK
Type of DeviceBREAST TISSUE MARKER CLIP
Manufacturer (Section D)
DEVICOR
cincinnati OH
MDR Report Key6349217
MDR Text Key68104620
Report NumberMW5068009
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 02/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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

Patient Treatment Data
Date Received: 02/19/2017 Patient Sequence Number: 1
Treatment
OTC MEDS: TEA
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