LOCALIZER
Report
- Report Number
- 3013649990-2021-00011
- Event Type
- Malfunction
- Date Received
- December 13, 2021
- Date of Event
- November 17, 2021
- Report Date
- December 3, 2021
- Manufacturer
- HEALTH BEACONS, INC
- Product Code
- NEU
- PMA / PMN Number
- K193189
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES 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.
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. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES 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.
IT WAS REPORTED THAT DURING A LOCALIZER PROCEDURE ON (B)(6) 2021, PIECES OF THE DEVICE BROKE OFF INSIDE THE PATIENT. NO OTHER INFORMATION IS AVAILABLE.
IT WAS REPORTED THAT DURING A LOCALIZER PROCEDURE ON (B)(6) 2021, PIECES OF THE DEVICE BROKE OFF INSIDE THE PATIENT. NO OTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1881577 | LOCALIZER | MARKER, RADIOGRAPHIC, IMPLANTABLE | NEU | HEALTH BEACONS, INC | HB110 | 22481822 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |