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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 4010-01-08-T4
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/26/2017
Event Type  malfunction  
Manufacturer Narrative
The hydromark breast biopsy site marker is used to mark tissue during a percutaneous breast biopsy procedure, visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and mri. One 4010-01-08-t4 hydromark was received on 5/30/2017 and investigated on 6/2/2017. The device was received in good condition. The device shows signs of being used in a procedure. The fixed ramp is missing from the device and was not returned thus preventing a full investigation or determining root cause. The device history records were reviewed and there were no non-conformances that would relate to this failure. It was confirmed that the pink plastic pledget (fixed ramp) was found on the tip of the probe and not left in the biopsy site. However, as the occurrence has the potential to result in patient consequence with the need for surgical intervention or other form of treatment, and pursuant to 21 cfr 803, we are submitting this medwatch report.
 
Event Description
The sales rep reported that pink plastic pledget (fixed ramp) broke off during deployment in the procedure. Pledget (fixed ramp) was found at tip of straw (outer sheath) near plastic targeting block.
 
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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)
MICRO STAMPING CORPORATION
12955 starkey rd.
suite 3700
largo FL 33773
Manufacturer Contact
shawna rose
300 e-business way
fifth floor
cincinnati, OH 45241
5138649178
MDR Report Key6608892
MDR Text Key76627993
Report Number3008492462-2017-00036
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130537
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 05/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Model Number4010-01-08-T4
Device Catalogue Number4010-01-08-T4
Device Lot Number200037113
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
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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