FDA Adverse Event
Injury
Summary report: N
XCELA
MDR report key: 23840123
·
Received December 18, 2025
Report
- Report Number
- 3008797795-2025-00045
- Event Type
- Injury
- Date Received
- December 18, 2025
- Date of Event
- July 21, 2018
- Report Date
- December 18, 2025
- Manufacturer
- PFM MEDICAL CPP SA
- Product Code
- LJT
- PMA / PMN Number
- K122402
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE MANUFACTURER CONDUCTED A DOCUMENTARY REVIEW ON THE BATCH PROVIDED: NO DEVIATION WAS FOUND. WITHOUT RETURNED PRODUCT FOR TECHNICAL INVESTIGATION, IT IS NOT POSSIBLE TO CONFIRM THE REPORTED DEFECT. THE RELATED RISKS ARE IDENTIFIED IN OUR RISK MANAGEMENT FILE AND PROCEDURE CLEARLY DESCRIBED IN THE IFU. THEREFORE, COMPLAINT IS CLASSIFIED AS NO DEFINITIVE CONCLUSION, UNVERIFIABLE (NO RETURN PRODUCT).
Description of Event or Problem · 0
PORT WAS IMPLANTED ON (B)(6) 2016 FOR THE PURPOSE OF CHEMOTHERAPY DELIVERY. CATHETER-RELATED INFECTION WAS DIAGNOSED ON (B)(6) 2018. THE PORT WAS REMOVED ON (B)(6) 2018.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2385828 | XCELA | PORT | LJT | PFM MEDICAL CPP SA | 136240000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| L |