RITE AID PREMIUM DOUCHE & ENEMA KIT

Description of Event or Problem

ON (B)(6) 2008, WHILE USING THE (B)(4) PREMIUM COMBINATION DOUCHE & ENEMA KIT DURING A SELF-PERFORMED ENEMA PROCEDURE, THE ENEMA PIPE BECAME DETACHED FROM THE HOSE AND BECAME LODGED IN THE PT'S RECTUM. ATTEMPTS MADE TO REMOVE THE ENEMA PIPE WERE NOT SUCCESSFUL AT HOME, SO THE PT WENT TO URGENT CARE WHERE THE DOCTOR WAS ALSO UNABLE TO REMOVE THE ENEMA PIPE. THE PT WAS TRANSPORTED TO THE HOSPITAL, WHERE THE ENEMA PIPE WAS SURGICALLY REMOVED. THE PT PERFORMING THE ENEMA PROCEDURE WAS (B)(6) ((B)(6) NOW). THE COMPLAINT REPORTS THAT THE PT HAD CONSIDERABLE BLOOD LOSS WHILE THE RECTAL PIPE REMAINED LODGED.

Additional Manufacturer Narrative

CUSTOMER FEEDBACK, CASE ID (B)(4) WAS RECEIVED ON (B)(6) 2010, HOWEVER, THE DATE OF THE INCIDENT WAS 2.5 YEARS EARLIER ON (B)(6) 2008. THE PATIENT/USER WAS AN (B)(6) FEMALE WHO HAS USED THIS TYPE OF PRODUCT IN THE PAST, HOWEVER, SHE PURCHASED A "NEW" COMBINATION KIT A FEW DAYS EARLIER, AND THIS WAS THE INITIAL USE OF THIS KIT. THE CUSTOMER FEEDBACK REPORTS THAT THE ENEMA PIPE BECAME DETACHED DURING A HOME, SELF-PERFORMED ENEMA PROCEDURE. THE PATIENT/USER REPORTS THAT ATTEMPTS TO REMOVE THE ENEMA AT HOME AND AT URGENT CARE WERE NOT SUCCESSFUL, AND NEEDED TO BE SURGICALLY REMOVED AT A MEDICAL CENTER. THE DEVICE HAS NOT, AND WE ARE TOLD WILL NOT BE RETURNED FOR EVALUATION SO WE CANNOT DETERMINE IF THERE IS A FAILURE OF THE DEVICE, OR IF IT WAS NOT ASSEMBLED CORRECTLY BY THE PATIENT/USER. APOTHECARY PRODUCTS INC. HAS NOT RECEIVED ANY ADDITIONAL SIMILAR COMPLAINTS IN THE 2.5 YEARS SINCE THE DATE OF THE EVENT. A HAZARD ANALYSIS WAS CONDUCTED ON 08/27/2010 TO REVIEW THE SEVERITY AND LIKELIHOOD OF OCCURRENCE OF HARM FOR THIS TYPE OF INCIDENT. APOTHECARY PRODUCTS INC. WILL REVIEW THE DIAMETER OF THE ENEMA PIPE COLLAR TO DETERMINE IF A MODIFICATION TO THE ENEMA PIPE COLLAR IS REQUIRED TO PREVENT THIS TYPE OF EVENT FROM OCCURRING IN FUTURE.