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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 01/27/2020
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 that after an ultrasound biopsy with a hydromark marker, product code 4010-02-15-t3, caused a reaction in the patient. The patient experienced redness and pain to the breast. No testing on the specific device has been conducted as the device was not returned for evaluation. 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 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 representative after procedure, st modality, a patient - had a reaction post biopsy. Patient complication details: redness and pain to the breast - sent to the er. The customer did not provide the necessary information to determine the severity of harm of the alleged injury. Devicor is reporting on the allegation of injury only. If any new additional relevant information is identified, the injury will be characterized accordingly. This incident has been recorded in complaint #(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
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 Key9748405
MDR Text Key192499015
Report Number3008492462-2020-00003
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2020
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
Device Lot NumberF11948401D
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 Received01/29/2020
Was Device Evaluated by Manufacturer? No
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: 02/24/2020 Patient Sequence Number: 1
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