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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
Lot Number F11814464D
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/15/2018
Event Type  malfunction  
Event Description
Patient had her biopsy and had two titanium clips placed in the area of both biopsies. When radiologist was sent her post mammo pictures, there were no clips to be found. Pt brought back to ultrasound to have x2 more clips placed that were visualized.
 
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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 Key8992347
MDR Text Key157456447
Report Number8992347
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 04/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberF11814464D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/23/2019
Event Location Outpatient Treatment Facility
Date Report to Manufacturer09/11/2019
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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