FDA Adverse Event
Injury
Summary report: N
INTERA 3000
MDR report key: 24866972
·
Received April 13, 2026
Report
- Report Number
- 3015537318-2026-00041
- Event Type
- Injury
- Date Received
- April 13, 2026
- Report Date
- April 13, 2026
- Manufacturer
- INTERA ONCOLOGY, INC
- Product Code
- LKK
- UDI-DI
- 00850014110147
- PMA / PMN Number
- P890055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
LITERATURE CITATION: TUMOR-TARGETED IL-12 (PDS01ADC) WITH HEPATIC ARTERY INFUSION PUMP THERAPY FOR COLORECTAL LIVER METASTASES: INTERIM ANALYSIS OF A NONRANDOMIZED PHASE II TRIAL. ALYSSA V. EADE, MD, EMILY C. SMITH, PHD, ET. AL. JCO ONCOL ADV 3, E2500173(2026) VOLUME 3, NUMBER 1 DOI: 10.1200/OA-25-00173 LITERATURE LISTS THE STUDY HAD 14 GRADE 3 OR HIGHER ADVERSE EVENTS AND SPECIFIES 2 ARE RELATED TO HAI (HEPATIC ARTERY INFUSION PUMP) THERAPY, BUT IT DID NOT DISCLOSE WHICH ONES LISTED WERE ASSOCIATED WITH HAI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513271 | INTERA 3000 | HEPATIC ARTERY INFUSION PUMP | LKK | INTERA ONCOLOGY, INC | AP-03000H | 00850014110147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| R | LEUCOVORIN, 5-FU, IRINOTECAN| LEUCOVORIN, 5-FU, OXALIPLATIN| SUBCUTANEOUS PDS01ADC |