THD SLIDE
Received Oct 18, 2013 · Event occurred Jan 27, 2010
Report 3006680097-2013-00002 · MDR key 3422805
Product problems
- Insufficient Device Problem Information
Patient
77 YR
- Diarrhea
- Tachycardia
- Urinary Retention
- Test Result
Narrative
Description of Event or Problem
FORTY EIGHT HRS POST OPERATIVE, PT COMPLAINED ABOUT PROBLEM DEFECATING. PROVIDED A FOLEY CATHETER TO TREAT URINARY RETENTION. DAY 3, COMPLAINED OF BAD DIARRHEA. BROUGHT PT BACK DAY 4 AND APPEARED TACHYCARDIC WITH A WHITE COUNT OF 20. THE DOCTOR SUSPECTED PELVIC SEPSIS, BUT WASN'T SURE WHERE IT CAME FROM. STARTING PT ON ANTIBIOTICS.
Additional Manufacturer Narrative
THD SPA BECAME AWARE OF THE EVENT VERY LATE BECAUSE IT WAS NOTIFIED BY (B)(6) ONLY IN JUN 2013, WHILE THE EVENT WAS DATED IN THE YR 2010. IN THIS CASE THD SPA CANNOT MAKE AN EVAL ABOUT THE EVENT; IN PARTICULAR IT CANNOT INVESTIGATE THE ADVERSE EVENT AND THE THD SLIDE DEVICE.
Remedial action
- Notification