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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
Catalog Number 4010-02-15-T3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 09/13/2021
Event Type  Injury  
Manufacturer Narrative
It was reported that the patient potentially suffered and allergic reaction after breast biopsy marker (hydromark) was inserted during the procedure. The patient attended the er with an anaphylactic allergic reaction. As the allergist was unfamiliar with our product and procedure the patient wanted to know more about the components of our product, so that they could be tested appropriately. Patient was provided with information on the hydrogel material. After following up for the clinical opinion on the pathologist and physician no response was received. Based on the information available we cannot confirm symptoms were a result of our device. Although we cannot confirm that the device caused the reported reaction, we are submitting this report due to the alleged allergic reaction.
 
Event Description
It was reported that on monday morning 13 september "i had a breast biopsy performed where the radiologist inserted one of your products - a breast biopsy site marker (hydromark). On monday afternoon i landed up in the emergency room with an anaphylactic allergic reaction. The allergist that i have been referred to is trying to rule out various possibilities, so as this was the only unfamiliar event of the day for me i would like to know what are the components of the hydromark. In other words, please would you inform me as to the metals that are in this product as i need to be tested to see if any of the substances are responsible for this serious allergic reaction. Please would you treat this as an urgent request. Thanks for prompt assistance with this (b)(6) no product information provided. " allergic reaction has not been confirmed to be caused by our device. This event has been reported as complaint number (b)(4).
 
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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 juanaines de la cruz
#20152 4-b
parque industrial, tijuana 22440
MX 22440
Manufacturer Contact
vivian rodriguez
300 e business way fifth floor
cincinnati, OH 45241
MDR Report Key12643678
MDR Text Key280068357
Report Number3008492462-2021-00009
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K060769
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number4010-02-15-T3
Device Lot NumberF12126332D
Was Device Available for Evaluation? No
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2021
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: 10/15/2021 Patient Sequence Number: 1
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