FDA Adverse Event
Injury
Summary report: N
PHILIPS MICRODOSE SI (MODEL: L50)
MDR report key: 5813512
·
Received July 21, 2016
Report
- Report Number
- 3009307584-2016-00001
- Event Type
- Injury
- Date Received
- July 21, 2016
- Date of Event
- February 4, 2016
- Report Date
- June 23, 2016
- Manufacturer
- PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB
- Product Code
- MUE
- PMA / PMN Number
- K123995
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
ON (B)(6) 2016, A PATIENT'S BREAST SCREENING WAS CONDUCTED USING PHILIPS MICRODOSE SI (MODEL: L50) SYSTEM. THE ACQUIRED IMAGE WAS REVIEWED BY RADIOLOGIST ON A SIEMENS PACS REVIEWING WORKSTATION. RADIOLOGIST REVIEWED THE IMAGE AND NO CLINICAL FINDING IS REPORTED. THE PATIENT FELT SOMETHING IN THE BREAST AND CAME BACK FOR CONSULTATION AND THEN THE PATIENT UNDERWENT DIAGNOSTIC SCANNING ON ANOTHER MICRODOSE SI (MODEL: L50 SYSTEM) ON (B)(6) 2016 AND RADIOLOGIST REPORTED CLINICAL FINDING IN THE BREAST IMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 466040 | PHILIPS MICRODOSE SI (MODEL: L50) | FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | MUE | PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB | 714047 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other |