MEDLINE HUDSON RCI
Received Jul 9, 2026 · Event occurred May 21, 2026
Report 1417592-2026-04890 · MDR key 25771081
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- Pressure Sore/Ulcer
Narrative
Description of Event or Problem
ACCORDING TO THE FACILITY, PRESSURE INJURIES WERE NOTED AROUND THE EAR IN MULTIPLE CASES OVER A THREE-MONTH PERIOD.
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY, PRESSURE INJURIES WERE NOTED AROUND THE EAR IN MULTIPLE CASES OVER A THREE MONTH PERIOD. THIS OCCURRED ON MULTIPLE DATES. STANDARD TREATMENT WAS GIVEN FOR THE PRESSURE INJURIES AND PREVENTION. THERE WAS NO FURTHER INFORMATION. IT HAS BEEN DETERMINED THAT THOUGH THE EVENT DID NOT INVOLVE A DEATH OR SERIOUS INJURY, RECURRENCE COULD CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.