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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 4010-02-15-T3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body Reaction (1868)
Event Date 07/08/2016
Event Type  Injury  
Manufacturer Narrative
One hydromark marker, product code 4010-02-15-t3, was placed at the time of the initial biopsy. The procedure was completed with no known patient hypersensitivity or immune response at that time. As the device was discarded by the customer, it could not be evaluated, nor could the incident be confirmed to be directly linked to our device. Although it could not be concluded that our device caused or contribute to this event, due to the reported adverse event, the subsequent procedure and/or treatment intervention, as well as medical consultation on similar events, this event has been determined to be reportable pursuant to 21 cfr 803. As such, we are submitting this medwatch report. Device discarded by customer.
 
Event Description
The sales rep reported that a patient had an ultrasound biopsy on (b)(6) 2016 with a hydromark clip placed. The patient has been to an urgent care and emergency room three times since with generalized rash, hives, numbness, tingling, swollen lips and tongue, etc.
 
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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 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 Key5822287
MDR Text Key50434755
Report Number3008492462-2016-00033
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 07/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2016
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2016
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: 07/26/2016 Patient Sequence Number: 1
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