LIBBE
Received Jan 25, 2013 · Event occurred Mar 7, 2011
Report 1648139-2013-00001 · MDR key 2934632
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Burning Sensation
- Discomfort
Narrative
Description of Event or Problem
(B)(6) PRESENTED FOR A COLON HYDROTHERAPY SESSION AND COMPLAINED OF DISCOMFORT AFTER INSERTION AND BEFORE STARTING THE THERAPY SESSION. (B)(6) INSISTED ON DOING THE THERAPY SESSION. (B)(6) COMPLAINED OF DISCOMFORT TWO OR THREE TIMES DURING THE SESSION. THE THERAPIST TOLD (B)(6) TO STOP AND CEASE THE THERAPY SESSION SEVERAL TIMES, BUT (B)(6) REFUSED TO TERMINATE THE THERAPY SESSION. (B)(6) COMPLETED THE THERAPY SESSION, THEN COMPLAINED OF BURNING IN ANUS. ANY ALLEGED INJURIES ARE UNVERIFIED. WE ARE NOW ATTEMPTING TO OBTAIN INFO ABOUT THE EVENT.
Additional Manufacturer Narrative
WE ARE ATTEMPTING TO OBTAIN MORE INFO ABOUT THE EVENT.