SENTINELLE
Received May 8, 2026 · Event occurred Apr 17, 2026
Report 1056069-2026-000002 · MDR key 25124604
Device
Generic name
Coil, Magnetic Resonance, Specialty
Manufacturer
Philips Medical Systems Nederland B.v.Model number
9896-032-16561Catalog number
989603213202
Product problems
- Improper or Incorrect Procedure or Method
- Insufficient Device Problem Information
Patient
73 YR · Female
- Blister
- Unspecified Tissue Injury
Narrative
Additional Manufacturer Narrative
PHILIPS HAS STARTED AN INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS COMPLETED.
Description of Event or Problem
PHILIPS RECEIVED A REPORT INVOLVING A PATIENT WHO UNDERWENT A RIGHT BREAST BIOPSY, RIGHT LATERAL APPROACH IN THE FEET FIRST PRONE POSITION, THE PATIENT FELT BURNING SENSATION DURING EXAM, UPON GETTING OFF THE TABLE RADIOLOGIST NOTICE REDNESS AND A LINEAR TYPE BLISTER MEDIAL STERNUM AREA ABOUT 4 INCHES IN LENGTH AND ABOUT 1-2 MM WIDE. COOLING WAS APPLIED FOR APPROXIMATELY 10 MINUTES BY THE MEDICAL DOCTOR. THE REPORTED INJURY MEETS THE CRITERIA FOR A SERIOUS INJURY.