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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARBON MEDICAL TECHNOLOGIES, INC. MAMMOSTAR BIOPSY SITE IDENTIFER (UNCONFIRMED) MARKER, RADIOGRAPHIC, IMPLANTABLE

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CARBON MEDICAL TECHNOLOGIES, INC. MAMMOSTAR BIOPSY SITE IDENTIFER (UNCONFIRMED) MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body Reaction (1868)
Event Type  Injury  
Manufacturer Narrative
A biopsy site identifier is a sterile, single-patient use device that is placed into soft tissue during a biopsy procedure to radiographically mark a surgical location. It is suspected that this adverse event is related to mammostar biopsy site identifiers but this could not be confirmed because no catalog number or lot identification information could be obtained. The procedure was completed, with three identifiers placed, with no reaction at that time. The patient reported a year later that all three sites developed some kind of tissue reaction "unconfirmed abscess. " all three identifiers have been removed and two sites have fully resolved. The third identifier was removed three weeks ago and the recovery is ongoing. No additional information has been able to be obtained. The device was not returned for evaluation. Biocompatibility testing has been conducted and has determined that the device is non-irritating and non-sensitizing. The device history record was not reviewed because lot identification information could not be obtained. Appropriate controls are in place, however, for every lot manufactured to ensure that no discrepancies exist before release, including packaging and sterilization records. The information contained herein is being provided to fda to comply with regulations relating to medical device reporting and is based on information submitted by others that may not be factually correct. This submission does not constitute a determination or admission that a device has malfunctioned or that a device is related to a death or injury.
 
Event Description
The patient reported that she had three biopsy site identifiers placed over one year ago. She reports experiencing some kind of tissue reaction "unconfirmed abscess. " all three identifiers have been removed and two sites have fully resolved. The third identifier was removed three weeks ago and the recovery is ongoing.
 
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Brand NameMAMMOSTAR BIOPSY SITE IDENTIFER (UNCONFIRMED)
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
CARBON MEDICAL TECHNOLOGIES, INC.
1290 hammond road
saint paul MN 55110 5876
Manufacturer (Section G)
CARBON MEDICAL TECHNOLOGIES, INC.
1290 hammond road
saint paul MN 55110 5876
Manufacturer Contact
andrew adams
1290 hammond road
saint paul, MN 55110-5876
6516538512
MDR Report Key7074481
MDR Text Key93446464
Report Number2134494-2017-00001
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 12/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/02/2017
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: 12/01/2017 Patient Sequence Number: 1
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