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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC. MAMMOMARK BREAST BIOPSY SITE MARKER BIOPSY SITE IDENTIFIER

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DEVICOR MEDICAL PRODUCTS INC. MAMMOMARK BREAST BIOPSY SITE MARKER BIOPSY SITE IDENTIFIER Back to Search Results
Model Number MAM3014
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 11/01/2018
Event Type  Injury  
Manufacturer Narrative
The mammomark breast biopsy site marker is used to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and "be permanently" by x-ray and mri. The device has not been returned for evaluation, which prevents a full investigation and analysis of the root cause at this time. Multiple attempts to gain additional incident information were made with no success. 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 "similiar" events, this has been determined to be reportable "purpuant" to 21 cfr 803. As such, we are submitting this medwatch report.
 
Event Description
Devicor medical products received a complaint from the sales representative stating, "after procedure, patient claiming a cormark has caused a rash on her arms". This complaint has been filed in our system as record number (b)(4).
 
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Brand NameMAMMOMARK 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
Manufacturer Contact
jill burnett
300 e. business way
fifth floor
cincinnati, OH 45241
5138649047
MDR Report Key8121651
MDR Text Key128958463
Report Number3008492462-2018-00084
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 11/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMAM3014
Device Catalogue NumberMAM3014
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2018
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

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