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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
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/29/2021
Event Type  malfunction  
Event Description
On (b)(6) 2021 two tags were implanted into patient's breast. The implant team did not have a localizer reader available to them, so they were unaware that the tag was not readable. This practice goes against device instructions as described in the localizer labeling. On (b)(6) 2021 health beacons received a complaint indicating that the localizer reader utilized during surgery was not reading the rfid tag at all, not even in the specimen post-procedure. Images taken on the day of the scheduled surgery showed that the tag had fractured inside the patient's tissue. This was the reason why the tag was not being read by the reader. After the excision surgery, the tag was confirmed to be broken. Despite multiple efforts, health beacons was unable to obtain information regarding breast density or any additional information from the implant team, as this is a separate organization from the reporting site. It was confirmed by the hologic representative that, except for the reported extended anesthesia time required to overcome the unknown broken tag difficulty, including trying to troubleshoot the reader, then locating the tag with imaging, and then recovering the broken tag, there were no other impacts to the patient reported. It was confirmed that the tag fragments were successfully removed on (b)(6) 2021 during the scheduled explant surgery, without the need for additional surgical intervention.
 
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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 Key11815729
MDR Text Key250821803
Report Number3013649990-2021-00004
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 04/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2021
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

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