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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEALTH BEACONS, INC LOCALIZER MARKER, RADIOGRAPHIC, IMPLANTABLE

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HEALTH BEACONS, INC LOCALIZER MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Model Number HB200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that during a procedure on a unknown date, during a localizer procedure the patient´s injury was bracketed with two localizer tags, that both tags fell out of the excised specimen prior to intra-operative imaging so the physician had to close the patient and end the case. No other information is available at the moment. No lot number is available. No additional information was received.
 
Manufacturer Narrative
Lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known. Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant. The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed. We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined. The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends. If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure. Reports for both device involved under 3013649990-2021-00013.
 
Manufacturer Narrative
Lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known. Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant. The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed. We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined. The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends. If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure. Reports for both device involved under 3013649990-2021-00013.
 
Event Description
It was reported that during a procedure on a unknown date, during a localizer procedure the patient´s injury was bracketed with two localizer tags, that both tags fell out of the excised specimen prior to intra-operative imaging so the physician had to close the patient and end the case. No other information is available at the moment. No lot number is available. No additional information was received.
 
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Brand NameLOCALIZER
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
HEALTH BEACONS, INC
250 campus drive
marlborough MA 01752
Manufacturer (Section G)
HOLOGIC, INC.
250 campus drive
marlborough, MA 01752
Manufacturer Contact
daniel guevara
562 parkway
coyol free zone building b24
san jose, alajuela 20102- CRI
CS   20102 CRI
MDR Report Key13005766
MDR Text Key285497919
Report Number3013649990-2021-00014
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHB200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/24/2021
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: 12/14/2021 Patient Sequence Number: 1
Treatment
LOCALIZER READER
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