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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

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DEVICOR MEDICAL PRODUCTS INC MAMMOMARK BREAST BIOPSY SITE MARKER Back to Search Results
Model Number MAM3001
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 07/30/2018
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. However, this failure 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, after procedure, the customer works with eviva system. The patient has been operated, because of maligne. In the histological results the following is described: a small eosinophilia surrounding the marker is suspicious of an allergic reaction.
 
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Brand NameMAMMOMARK BREAST BIOPSY SITE MARKER
Type of DeviceBIOPSY SITE MARKER
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 Key7754382
MDR Text Key116202754
Report Number3008492462-2018-00060
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K082278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 08/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMAM3001
Device Catalogue NumberMAM3001
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 Received07/30/2018
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: 08/06/2018 Patient Sequence Number: 1
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