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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

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DEVICOR MEDICAL PRODUCTS, INC. HYDROMARK BREAST BIOPSY SITE MARKER Back to Search Results
Model Number 4010-01-11-T3
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 04/01/2019
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 week, and be permanently visible by x-ray and mri. The device has not been returned for evaluation, which prevents a full investigation and analysis of a root cause at this time. However, this failure mode has been identified in the risk management file for the effects of potential foreign body reaction with a potential for injury to the patient and/or user. Follow up medical intervention may be necessary. Although it could not be concluded that our device caused or contributed to this event, through evaluation by our medical advisor on similar events, this has been determined to be reportable pursuant to 21 cfr 803.
 
Event Description
Devicor medical products, inc. Received a report from the distributor stating, "marker clip was inserted in (b)(6) 2018. Patient follow up in (b)(6) 2019 showed a new nodule around the clip. Suspected to be a reaction to the gel marker clip. Marker is still in patient's breast and not removed". This had been documented in our system as report # (b)(4).
 
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Brand NameHYDROMARK BREAST BIOPSY SITE MARKER
Type of DeviceBREAST BIOPSY SITE MARKER
Manufacturer (Section D)
DEVICOR MEDICAL PRODUCTS, INC.
300 e. business way
fifth floor
cincinnati OH 45241
Manufacturer (Section G)
DEVICOR MEDICAL PRODUCTS, INC.
300 e. business way
fifth floor
cincinnati OH 45241
Manufacturer Contact
jill burnett
300 e. business way
fifth floor
cincinnati, OH 45241
MDR Report Key8959919
MDR Text Key158978968
Report Number3008492462-2019-00042
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
PMA/PMN Number
K060769
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial
Report Date 09/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/04/2020
Device Model Number4010-01-11-T3
Device Catalogue Number4010-01-11-T3
Device Lot Number200042056
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 Received08/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/04/2019 Patient Sequence Number: 1
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