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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SENOMARK ULTRA MARKER BIOPSY INSTRUMENT

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BARD PERIPHERAL VASCULAR, INC. SENOMARK ULTRA MARKER BIOPSY INSTRUMENT Back to Search Results
Catalog Number UNK SENOMARK ULTRA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Breast Discomfort/Pain (4504)
Event Date 06/24/2021
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
 
Event Description
It was reported in a case report of ¿innovative use of magnetic resonance imaging-guided focused ultrasound surgery for non-invasive breast cancer¿, post procedure one patient experienced breast pain. The current status of the patient is unknown.
 
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Brand NameSENOMARK ULTRA MARKER
Type of DeviceBIOPSY INSTRUMENT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
INFUS MEDICAL (THAILAND)
706 moo 4
bangpoo ind estate
samutprakarn province 10280
TH 10280
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12195664
MDR Text Key262417765
Report Number2020394-2021-01356
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K123911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Reporter Occupation
Type of Report Initial
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK SENOMARK ULTRA
Device Lot NumberUNKNOWN
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 Received06/24/2021
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: 07/20/2021 Patient Sequence Number: 1
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