• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME CORMARK MARKER, RADIOGRAPHIC, IMPLANTABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME CORMARK MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Model Number MAM3014
Device Problems Positioning Failure (1158); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2018
Event Type  malfunction  
Event Description
Patient was undergoing ultrasound guided core needle biopsy in l breast. Radiologist deployed site identifier clip which felt different. Radiologist did not have to push as hard as normal to deploy it (less resistance). On post procedure mammogram, no clip was visualized. A second clip was immediately placed with no issues. Post mammogram showed successful deployment of second clip. No harm to patient. Incident delayed procedure by 10-15 minutes. Manufacturer response for biopsy site identifier, biopsy site identifier (per site reporter): manufacturer instructed to notify local representative. Facility will be credited for malfunctioning product.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAMMOTOME CORMARK
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
DEVICOR MEDICAL PRODUCTS, INC.
300 e business way #5
cincinnati OH 45241
MDR Report Key7315914
MDR Text Key101611758
Report Number7315914
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2019
Device Model NumberMAM3014
Device Catalogue NumberMAM3014
Device Lot NumberF11749456D
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/28/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer02/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-