WALGREEN COMBINATION
Received May 5, 2005 · Event occurred Mar 11, 2005
Report 1520456-2005-00002 · MDR key 599884
Device
Generic name
Combination Enema Kit
Manufacturer
Hospira, Inc.Model number
NACatalog number
02091
Lot number
UNK
Product problems
- Break
Patient
40 YR
- Surgical procedure
- Foreign body, removal of
- Hospitalization required
Narrative
Description of Event or Problem
SUBSEQUENT TO THE INITIAL MEDWATCH SUBMISSION THE FOLLOWING INFORMATION WAS RECEIVED: THE PT HAD A PROCTOSCOPY TO REMOVE THE APPLICATOR. THE PT WAS DISCHARGED IN 2004 WITH A PRESCRIPTION FOR AUGUMENTIN 500MG THREE TIMES DAILY AND AN UNSPECIFIED PAIN MEDICATION.
Description of Event or Problem
REPORT RECEIVED OF APPLICATOR BREAKAGE. WHILE THE CONSUMER WAS ADMINISTERING AN UNSPECIFIED AMOUNT OF SOLUTION RECTALLY, THE "NOZZLE" (APPLICATOR) EITHER DISCONNECTED OR BROKE. THE CUSTOMER WAS UNABLE TO REMOVE THE APPLICATOR AND WENT TO THE E.R.. THE PT HAD SURGERY TO REMOVE THE APPLICATOR AND WAS REPORTELDY HOSPITALIZED FOR 4 DAYS.