MAUDE Adverse Event Report: HEALTH BACONS, INC LOCALIZER; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number HB205-10

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.Therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.

Event Description

It was reported that during a localizer procedure on (b)(6) 2022, the tag broke sometime between the placement and the surgery.No injury to the patient was reported, the device broke sometime after the tag placement, the mammography after the placed looked normal.The procedure was completed and no additional procedures required at the moment.An image provided could see the tag broken on the specimen removed.No other information at the moment.

• Brand Name: LOCALIZER
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HEALTH BACONS, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 14209529
• MDR Text Key: 293173196
• Report Number: 3013649990-2022-00010
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00855436007044
• UDI-Public: 00855436007044
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HB205-10
• Device Catalogue Number: HB205-10
• Device Lot Number: 48461
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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 Sex: Female