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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 BIOPSY SITE IDENTIFIER

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DEVICOR MEDICAL PRODUCTS, INC HYDROMARK BREAST BIOPSY SITE MARKER BIOPSY SITE IDENTIFIER Back to Search Results
Model Number 4010-02-15-T4
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Event Date 03/19/2020
Event Type  Injury  
Manufacturer Narrative
The hydromark breast biopsy site marker is used to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and mri. It was reported by sales rep that after successful deployment of the hydromark ( 4010-02-15-t4) an artifact was seen on the post mamogram. This incident has been recorded in complaint #(b)(4). An investigation was performed and based on observed conditions, a detailed analysis was conducted in the manufacturing assembly line to determine what could have potentially be caused this event. During the review of the operations of hydromark line, it was found that the line works according to what is indicated in the procedures (mp's). All product inspections and manufacture documentation of the hydromark process line is within specification and in accordance to all required process documentation. Manufacturing process and dhr have been reviewed all testing performed were within specification for the specified lot. Devicor could not conclude that our device caused or contributed to this event, due to the allegation of an artifact seen on the post mamogram this has been determined to be reportable pursuant to 21 cfr 803. As such, we are submitting this medwatch report.
 
Event Description
It was reported by sales rep that after successful deployment of the hydromark ( 4010-02-15-t4) an artifact was seen on the post mamogram. This incident has been recorded in complaint #(b)(4). Devicor could not conclude that our device caused or contributed to this event, due to the allegation of an artifact seen on the post mamogram this has been determined to be reportable pursuant to 21 cfr 803. As such, we are submitting this medwatch report.
 
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Brand NameHYDROMARK BREAST BIOPSY SITE MARKER
Type of DeviceBIOPSY SITE IDENTIFIER
Manufacturer (Section D)
DEVICOR MEDICAL PRODUCTS, INC
300 e. business way
fifth floor
cincinnati, oh
Manufacturer (Section G)
DEVICOR MEDICAL PRODUCTS DE MEXICO
sor juanaines de la cruz
#20152 4-b
parque industrial, 22440
MX 22440
Manufacturer Contact
jack cummings
300 e business way
fifth floor
cincinnati, oh 
MDR Report Key9965873
MDR Text Key194136562
Report Number3008492462-2020-00006
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4010-02-15-T4
Device Catalogue Number4010-02-15-T4
Device Lot NumberF11931422D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/15/2020 Patient Sequence Number: 1
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