MalfunctionFCE
GENT-L-KARE
Received May 23, 2019 · Event occurred Sep 6, 2017
Report 8636055 · MDR key 8636055
Device
Generic name
Enema Kit
Manufacturer
Medegen Medical Products, LlcProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
24820 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PATIENT PRESENTED TO OUTPATIENT CLINIC FOR ROUTINE FOLLOW UP. TOLD PHYSICIAN THAT SHE HAD BLUE PLASTIC ITEM FALL OUT OF HER RECTUM APPROXIMATELY 3 WEEKS AGO. CONCERNS THAT THE CAP AND TUBING ARE VERY SIMILAR IN COLOR, MAKING IT LESS OBVIOUS TO REMOVE THE CAP BEFORE ADMINISTRATION.