InjuryFCD
EZEM SUPER XL ENEMA BAG SYSTEM
Received Aug 15, 2000 · Event occurred Aug 9, 2000
Report MW1019656 · MDR key 290944
Device
Product problems
- Misplacement
- Other (for use when an appropriate device code cannot be identified)
Patient
44 YR
- Laceration(s)
- Surgical procedure, additional
- Hospitalization required
Narrative
Description of Event or Problem
INTRODUCTION OF EZEM SUPER XL ENEMA TIP INTO THE VAGINA CAUSED TWO VAGINAL LACERATIONS WHICH REQUIRED SURGICAL INTERVENTION.