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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEALTH BEACONS INC LOCALIZER TAG APPLICATOR

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HEALTH BEACONS INC LOCALIZER TAG APPLICATOR Back to Search Results
Model Number HB300-10
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/24/2021
Event Type  malfunction  
Event Description
On 26-mar-2021 health beacons became aware of an incident at lifebridgehealth breast center, in (b)(6). The doctor was placing a localizer tag under stereo guidance into a patient and the localizer tag cracked in half. The tag was placed next to a clip, in perfect position. The doctor confirmed that the patient's breast tissue was very dense and hard due to scar tissue. The tag could not be detected by a reader, as it was not transmitting. The patient was taken to ultrasound, where the clip and tag were seen. The health beacons investigator communicated with hologic representatives to gather more information from account representative about this incident. Images were provided, which show broken tag (attached to this report). It was confirmed that on (b)(6) 2021, the tag was removed, together with target tissue, during the regularly scheduled surgery. It was confirmed that all fragments were contained in the specimen and removed from the patient, without additional surgical intervention. The removed tissue was identified as cancerous, which most likely contributed to the high density of the tissue. It is noted by health beacons that in this instance of tag breakage, the needle was being pushed against resistance, contrary to the instructions for use guidance.
 
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Brand NameLOCALIZER
Type of DeviceTAG APPLICATOR
Manufacturer (Section D)
HEALTH BEACONS INC
250 campus drive
marlborough MA 01752
Manufacturer (Section G)
RANFAC CORPORATION
30 doherty avenue
avon MA 02322
Manufacturer Contact
sumanesh agrawal
250 campus drive
marlborough, MA 01752
5203998155
MDR Report Key11719036
MDR Text Key259988391
Report Number3013649990-2021-00003
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 company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 03/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHB300-10
Device Lot Number47023
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2020
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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