LOCALIZER
Report
- Report Number
- 3013649990-2021-00012
- Event Type
- Injury
- Date Received
- December 6, 2021
- Date of Event
- November 5, 2021
- Report Date
- January 4, 2022
- Manufacturer
- HEALTH BEACONS, INC
- Product Code
- NEU
- PMA / PMN Number
- K193189
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- 003
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.
LOCALIZER DEVICE RECEIVED : VISUAL INSPECTION WAS PERFORMED, THE DISPOSABLE LOOKED AS INTENDED. READER/SURGICAL PROBE FUNCTIONAL TEST WAS ALSO PERFORMED, THE DEVICE PASSED THE TEST. DEVICE WORKED AS INTENDED. COMPLAINT NOT CONFIRMED. THIS OBSERVATION WILL BE MONITORED AND TRENDED. 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.
IT WAS REPORTED THAT DURING A LOCALIZER PROCEDURE ON (B)(6) 2021 THE PHYSICIAN WAS EXPERIENCING ISSUES WITH THE LOCALIZER READER REGARDING INACCURATE MEASUREMENTS ,THE PHYSICIAN REMOVED MORE TISSUE FROM THE PATIENT THAN INTENDED. A SECOND READER WAS USED AND THE PROCEDURE COULD BE COMPLETED. NO ADDITIONAL MEDICATION OR IMAGING WAS REQUIRED. THE LOCALIZER TAG WAS REMOVED FROM THE PATIENT SUCCESSFULLY. NO OTHER INFORMATION IS AVAILABLE.
IT WAS REPORTED THAT DURING A LOCALIZER PROCEDURE ON (B)(6) 2021 THE PHYSICIAN WAS EXPERIENCING ISSUES WITH THE LOCALIZER READER REGARDING INACCURATE MEASUREMENTS ,THE PHYSICIAN REMOVED MORE TISSUE FROM THE PATIENT THAN INTENDED. A SECOND READER WAS USED AND THE PROCEDURE COULD BE COMPLETED. NO ADDITIONAL MEDICATION OR IMAGING WAS REQUIRED. THE LOCALIZER TAG WAS REMOVED FROM THE PATIENT SUCCESSFULLY. NO OTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1837769 | LOCALIZER | MARKER, RADIOGRAPHIC, IMPLANTABLE | NEU | HEALTH BEACONS, INC | HB100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other | LOCAZLIER TAG |