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

Model Number HB205-10

Device Problem No Apparent Adverse Event (3189)

Patient Problems Hypersensitivity/Allergic reaction (1907); Local Reaction (2035)

Event Date 05/06/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 , the localizer tag was implanted in patient.15 minutes after implantation, the patient experienced an allergic reaction.The patient has known allergies to tape adhesive, latex, alum and penicillin.The allergic reaction appeared as a rash on the patient's back; it was not local to the implantation area.It was learned that this patient had also experienced an allergic reaction to the placement of a non-health beacons marker several days earlier.On (b)(6) 2021 health beacons/hologic reached out to the radiologist to inquire if the use of lidocaine could have possibly caused the patient's allergic reactions, since it was injected prior to the procedure.The radiologist's opinion was that the reaction was not due to the lidocaine used, as the patient had mentioned that she had received lidocaine before at the dentist, with no issues.It was reported that the rash resolved itself without intervention.Health beacons attempted to obtain additional information related to the removal of the tag and the integrity of the tag after implantation, but multiple attempts to obtain this information were unsuccessful.There is no additional information about the tag and its removal available for the investigation.Given that the rash resolved itself without intervention and that the patient experienced a similar reaction to an unrelated product in the days prior to this event, health beacons has concluded that it is very unlikely that the rash is related to the tag or the tag applicator materials, which have been tested for biocompatibility.No other complaints of this type have been received over the span of more than 50,000 tag implantations in three years.This event is being reported out of an abundance of caution.

• Brand Name: LOCALIZER
• Type of Device: TAG 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
• MDR Report Key: 11942584
• MDR Text Key: 259986931
• Report Number: 3013649990-2021-00005
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HB205-10
• Device Lot Number: 46517
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other