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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC HYDROMARK BIOPSY SITE IDENTIFIER

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DEVICOR MEDICAL PRODUCTS, INC HYDROMARK BIOPSY SITE IDENTIFIER Back to Search Results
Model Number 4010-01-11-T3
Device Problem Use of Device Problem (1670)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/05/2021
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 currently under investigation. Supplemental report to follow.
 
Event Description
It was reported by sales rep after clip placement/biopsy site marking procedure, tip of applicator was broken. The hydromark was pulled out first, not with the probe. Tip of applicator was broken. The damaged part is not expected to remain in the patient body. Procedure was completed. The doctor later checked if the hydromark fragment was in the body, but was not sure. As a result of the biopsy, the patient has to undergo surgery and the area where the hydromark was placed is also removed. This event is documented in our system as complaint# (b)(4).
 
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Brand NameHYDROMARK
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, 22440
MX 22440
Manufacturer Contact
vivian rodriguez
300 e business way
fifth floor
cincinnati, OH 45241
MDR Report Key11787304
MDR Text Key249453116
Report Number3008492462-2021-00007
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K121113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 07/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4010-01-11-T3
Device Catalogue Number4010-01-11-T3
Device Lot NumberF12037415D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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