GENT-L-KARE
Received May 9, 2019 · Event occurred Mar 20, 2019
Report MW5086537 · MDR key 8600384
Device
Product problems
- Use of Device Problem
Patient
57 YR
- Ulceration
- Ulceration
Narrative
Description of Event or Problem
PT CAME TO GI LAB FOR FLEXIBLE SIGMOIDOSCOPY. WHEN PROCEDURE STARTED AND SCOPE INSERTED, A CAP FROM AN ENEMA WAS FOUND APPROX 2 INCHES INTO RECTUM. PT SUSTAINED MUCOSAL ULCERATION FROM THE CAP OF AN ENEMA. WE UNDERSTAND THIS WAS USER ERROR AS ENEMA CAP WAS NOT REMOVED BEFORE ENEMA GIVEN. ALTHOUGH, WE FELT THIS WAS A REPORTABLE EVENT AS THE TUBING AND ENEMA CAP ARE THE SAME COLOR - BLUE. FDA SAFETY REPORT ID# (B)(4).