MEDLINE
Received Jun 19, 2026 · Event occurred May 21, 2026
Report 1417592-2026-02685 · MDR key 25561503
Device
Product problems
- Sharp Edges
Patient
NA · Male
- Laceration(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2026 "A PATIENT WAS CUT...BY THE URINAL, WITH THE NURSE REPORTING BLOOD DROPPING FROM OUTSIDE THE URINAL" AND "SUPERFICIAL SKIN INJURY WITH BLEEDING" WAS OBSERVED AFTER USING THE DEVICE. PER THE FACILITY, "APPROPRIATE CARE WAS PROVIDED PER CLINICAL GUIDELINES."
Additional Manufacturer Narrative
IT WAS REPORTED THAT ON (B)(6) 2026 "A PATIENT WAS CUT...BY THE URINAL, WITH THE NURSE REPORTING BLOOD DROPPING FROM OUTSIDE THE URINAL" AND "SUPERFICIAL SKIN INJURY WITH BLEEDING" WAS OBSERVED AFTER USING THE DEVICE. PER THE FACILITY, "APPROPRIATE CARE WAS PROVIDED PER CLINICAL GUIDELINES." 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.