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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 HB200-10
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/08/2021
Event Type  malfunction  
Event Description
On (b)(6) -2021, health beacons became aware of an incident at norton pavilion breast center in louisville, ky. Patient was having a health beacons tag placed with a 10cm tag applicator, and according to the complaint, the tag shattered while being deployed into the breast. The tag had been detected prior to opening the package, but was not detectable after deployment. Health beacons had several communications with the breast surgical territory manager between (b)(6) 2021 and (b)(6) 2021 to investigate the incident and collect information about it. It was established that the tag applicator used was an original model, 10 cm applicator. It was also established that the implant procedure was completed under stereo - xray. It was confirmed that during the procedure, the clinician was pushing against resistance. It was determined that the ifu warning was not followed, which indicates that if resistance is encountered, the needle should be repositioned, and the user should never apply strong forces in order to overcome the obstacle. Two images of the implanted tag (taken orthogonally) were provided. It was determined, through the review of these images, that the body of the tag looked intact, and that it was surrounded by several fragments, presumably glass. On monday (b)(6) 2021, the tag was removed, and according to the surgeon removal went well and "the tag came out all together". The tag looked intact, and there were no discernable glass fragments left over in healthy tissue after target tissue was removed. No health impact to the patient was identified, and no extra procedures, scans, or tissue removal were required. An image of the excised tissue was provided.
 
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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)
RANFRAC CORPORATION
30 doherty avenue
avon MA 02322
Manufacturer Contact
sumanesh agrawal
250 campus drive
marlborough, MA 01752
5203998155
MDR Report Key11308706
MDR Text Key252001345
Report Number3013649990-2021-00001
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 01/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHB200-10
Device Lot Number46517
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/26/2020
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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