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U.S. Department of Health and Human Services

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

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DEVICOR MEDICAL PRODUCTS, INC. HYDROMARK MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Model Number 4010-02-15-T4
Device Problem Failure to Fire (2610)
Patient Problem No Information (3190)
Event Date 11/12/2018
Event Type  malfunction  
Event Description
A t4 breast biopsy marker failed to deploy in two cases on the same day. In both cases, a t3 breast biopsy marker clip was immediately deployed since the t4 marker could not be visualized on ultrasound. Mammography followed on each case and revealed a single t3 breast biopsy marker clip. Staff removed all t4 marker clips from the supply room for return to the supplier.
 
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Brand NameHYDROMARK
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
DEVICOR MEDICAL PRODUCTS, INC.
300 e-business way
fifth floor
cincinnati OH 45241
MDR Report Key8280935
MDR Text Key134209944
Report Number8280935
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/21/2018,11/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2019
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number4010-02-15-T4
Device Catalogue Number4010-02-15-T4
Device Lot NumberF11820475D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/21/2018
Event Location Outpatient Diagnostic Facility
Date Report to Manufacturer01/28/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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