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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC MAMMOMARK BIOPSY SITE IDENTIFIER

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DEVICOR MEDICAL PRODUCTS, INC MAMMOMARK BIOPSY SITE IDENTIFIER Back to Search Results
Model Number MAM3008
Device Problem Use of Device Problem (1670)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/15/2021
Event Type  Injury  
Manufacturer Narrative
The mammomark biopsy site identifier is a sterile, single use device intended for use after an open surgical or percutaneous breast biopsy procedure to mark the biopsy site. The device is not available for analysis, which precludes a full investigation and analysis of the root cause. However, this failure mode is identified in the risk management file and will occur at the end of the procedure and involves the marker tip physically breaking. The failure mode involves the tip of a side deploy marker shearing on the cutter of a disposable probe and separating from the body of the marker. Should this failure mode occur, there is a chance the broken marker tip may be left in the patient's breast. Current ifu lists this failure mode as a potential adverse event if device is misused. Based on patient consequences of unintended piece of the device of the device left in the biopsy site, we are submitting this medwatch report.
 
Event Description
It was reported by the affiliate that during a clip placement/ biopsy site marking procedure at the end of the procedure, the radiologist tried to place a biopsy marker. But the marker guide extremity broke inside the patient's breast leaving a 16mm debris in the breast. This event is documented in our system as (b)(4).
 
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Brand NameMAMMOMARK
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 juanaines de la cruz
#20152 4-b
parque industrial, 22440
MX 22440
Manufacturer Contact
vivian rodriguez
300 e business way
fifth floor
cincinnati, OH 45241
MDR Report Key11654167
MDR Text Key249709254
Report Number3008492462-2021-00006
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeFR
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 04/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMAM3008
Device Catalogue NumberMAM3008
Device Lot NumberF12043206D
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 Received03/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2020
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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