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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 4010-04-09-T4
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 07/22/2018
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 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 hypersensitivity 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. As such, we are submitting this medwatch report.
 
Event Description
It was reported by the sales rep that during procedure, hydromark was placed weeks ago. Patient has presented with persistent rach which might be related to infection or allergic reaction. Composition of marker has been requested. Due to time lapse since placement the product code and lot# are probably wrong. Modality unknown. The procedure was completed with the original device.
 
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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 MEDICAL
sor juana ines de la cruz
#20152 4-b, parque industrial
tijuana, baja california 22440
MX 22440
Manufacturer Contact
shawna rose
300 e-business way
fifth floor
cincinnati, OH 45241
5138649178
MDR Report Key7744951
MDR Text Key115890550
Report Number3008492462-2018-00056
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
PMA/PMN Number
K121113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 08/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4010-04-09-T4
Device Catalogue Number4010-04-09-T4
Device Lot NumberF11000228871
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/02/2018 Patient Sequence Number: 1
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