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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 40100315T3SHOR
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 04/05/2018
Event Type  malfunction  
Event Description
Atec clip was inserted into the right breast and clicked to deploy. Patient then went to mammogram for a follow-up mammogram to show clip placement. No clip was seen so she had to come back to ultrasound and have her band aids and steri strips removed to insert a core clip, which worked.
 
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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 Key7453697
MDR Text Key106302638
Report Number7453697
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 04/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number40100315T3SHOR
Device Lot Number200038945
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 FDA04/13/2018
Event Location Hospital
Date Report to Manufacturer04/13/2018
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?
Type of Device Usage

Patient Treatment Data
Date Received: 04/24/2018 Patient Sequence Number: 1
Treatment
NO
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