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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEALTH BEACONS, INC. LOCALIZER TAG APPLICATOR S

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HEALTH BEACONS, INC. LOCALIZER TAG APPLICATOR S Back to Search Results
Model Number HB300-05
Device Problem Material Separation (1562)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/28/2020
Event Type  malfunction  
Event Description
On 01-jun-2020 health beacons received complaint (b)(4). The complaint indicated that the localizer capsule (sheath) was missing from the tag when it was removed from patient. The tag was exposed during surgery and placed on back table. The representative indicated that the surgeon thought she may have touched the tag with the electrocautery device. Several requests for additional information to facilitate the investigation of the complaint have been submitted as follows: week of 01-jun-2020 - text was sent to representative, indicating that we needed additional information to investigate issue. - no response. 09-jun-2020 - emailed indicating that the complaint would be handled as a reportable event, and asking if the sheath was discovered during pathology of the resected tissue, or if an ultrasound was conducted on the patient to look for any trace of the sheath in the breast. Response: representative indicated that they did not have the information but would ask the physician on 12-jun-2020. 12-jun-2020 - follow up email was sent asking if the physician had been able to provide additional information. - no response. 17-jun-2020 - follow up email was sent requesting information. Response: on 19-jun-2020 representative sent a text to the physician requesting information. 30-jun-2020: representative visited the hospital to follow up in person as the surgeon has not responded to voicemails and texts. As it has been difficult to obtain information from the hospital because of personnel restrictions due to covid-19, we have not been able to fully understand the event, but out of an abundance of caution, we are reporting this incident as a device malfunction. The sheath may have melted fully or partially from the tag, leaving it unrecognizable but still in the tissue; it may have separated but remained in the excised tissue or it may have separated and remained in the breast (this is the least likely scenario, because it would mean it also migrated). Even in the event the sheath remains in the patient's breast, it is not being considered a serious injury, as the device is approved as a permanent implant. If additional information about the incident is obtained, a follow-up report will be submitted.
 
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Brand NameLOCALIZER
Type of DeviceTAG APPLICATOR S
Manufacturer (Section D)
HEALTH BEACONS, INC.
250 campus drive
marlborough, ma
Manufacturer (Section G)
RANFAC CORPORATION
30 doherty avenue
avon, ma
Manufacturer Contact
dhaval saraiya
250 campus drive
marlborough, ma 
3034835
MDR Report Key10228606
MDR Text Key232760260
Report Number3013649990-2020-00002
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190932
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 05/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/24/2021
Device Model NumberHB300-05
Device Lot Number43084
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/13/2019
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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