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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC. HYDROMARK BREAST BIOPSY SITE MARKER

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DEVICOR MEDICAL PRODUCTS INC. HYDROMARK BREAST BIOPSY SITE MARKER Back to Search Results
Model Number 4010-03-09-T3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/03/2019
Event Type  Injury  
Manufacturer Narrative
The hydromark biopsy site identifier is a sterile, single use device intended for use after an open surgical or percutaneous breast biopsy procedure to mark the biopsy site. The device is not available for analysis, which precludes a full investigation and analysis of the root cause. A post marker placement x-ray was forwarded from the end user and it appears the plunger spring tip of the applicator was sheared on the cutter of the disposable probe in the breast while removing the applicator. The instructions for use state, "remove the hydromark applicator and the mammotome revolve biopsy probe together as a single unit from the site and obtain images to confirm marker placement". We are submitting this report based upon the patient consequence of an unidentified fragment in the biopsy site, and the additional surgical procedure required to remove the fragment.
 
Event Description
Devicor medical products received a report from sales stating, "a biopsy was performed on a patient and a portion of the device was left behind in the patient. " the fragment was surgically removed. No patient complications. This has been documented in our system as record # (b)(4).
 
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Brand NameHYDROMARK BREAST BIOPSY SITE MARKER
Type of DeviceBIOPSY SITE MARKER
Manufacturer (Section D)
DEVICOR MEDICAL PRODUCTS INC.
300 e. business way
fifth floor
cincinnati OH 45241
Manufacturer (Section G)
DEVICOR MEDICAL PRODUCTS DE MEDICAL
sor juana ines de la cruz
#20152 4-b, parque industrial
tijuana, baja california
Manufacturer Contact
jill burnett
300 e. business way
fifth floor
cincinnati, OH 45241
MDR Report Key8267938
MDR Text Key133761604
Report Number3008492462-2019-00002
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130537
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4010-03-09-T3
Device Catalogue Number4010-03-09-T3
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/22/2019 Patient Sequence Number: 1
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