FDA Adverse Event
Injury
Summary report: N
XCELA
MDR report key: 23487801
·
Received November 6, 2025
Report
- Report Number
- 3008797795-2025-00031
- Event Type
- Injury
- Date Received
- November 6, 2025
- Manufacturer
- PFM MEDICAL CPP
- Product Code
- LJT
- PMA / PMN Number
- K072481
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
MANUFACTURER IS EVALUATING THE COMPLAINT AND ANY NEW CONCLUSIONS WILL BE SUBMITTED IN A FOLLOW UP REPORT TO FDA.
Description of Event or Problem · 0
ON OR ABOUT (B)(6) 2014, PATIENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER 132881000. THE DEVICE WAS IMPLANTED BY DR. (B)(6) AT (B)(6) MEDICAL CENTER IN (B)(6), FOR CHEMOTHERAPY DELIVERY. ON OR ABOUT (B)(6) 2017, PATIENT'S PORT WAS REMOVED BY DR. (B)(6) AT (B)(6) MEDICAL CENTER IN (B)(6) DUE TO PAIN AROUND THE PORT SITE FROM AN INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2465649 | XCELA | PORT | LJT | PFM MEDICAL CPP | 132881000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| L |