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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-T3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414); Patient Problem/Medical Problem (2688)
Event Date 12/22/2017
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. One hydromark marker, product code 4010-02-15-t3, was placed at the time of the initial biopsy. The procedure was completed with no known patient hypersensitivity or immune response at that time. Patient then presented to the er later in the evening with hives, shortness of breath and swelling of the tongue. Patient was treated with steroids and benadryl and released. Patient returned to the er two additional times all within 24 hours. An allergist was consulted and it was recommend that the marker be removed. Patient was then scheduled for a stereotactic procedure to remove the marker. Marker was removed from patient breast by dr. Jean warner within 48 hours of initial placement. Patient's symptoms improved once the marker was removed. It was recommended that the patient undergo allergy testing. However, due to complications with the iv during the er visits (phlebitis) this cannot be conducted for another 6 weeks. Patient's biopsy results came back benign. No testing on the specific device has been conducted. The applicator portion was disposed of at the conclusion of the biopsy procedure per internal medical facility procedures. However, sensitivity, cytoxicity and other reaction testing was conducted as part of the initial qualification of this device. No known reactions similar to those reported in this event were reported during this testing. Although it could not be concluded that our device caused or contributed to this event, due to the reported adverse event as well as medical consultation on similar events, this has been determined to be reportable pursuant to 21 cfr 803. As such, we are submitting this medwatch report.
 
Event Description
The sales rep reported that patient had an allergic reaction to hydromark. They are running allergy tests on patient to determine if in fact it is the hydromark.
 
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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 45241
Manufacturer (Section G)
DEVICOR MEDICAL PRODUCTS DE MEXICO
sor juana ines de la cruz
#20152 4-b, parque industrial
tijuana, baja california 22440
MX 22440
Manufacturer Contact
shawna rose
300 e-business way
fifth floor
cincinnati, OH 45241
5138649178
MDR Report Key7252498
MDR Text Key99376173
Report Number3008492462-2018-00008
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060769
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 01/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4010-02-15-T3
Device Catalogue Number4010-02-15-T3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/08/2018 Patient Sequence Number: 1
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