Description of Event or Problem · 1
PATIENT HAD ANAPHALACTIC REACTION TOWHAT WE SUSPECT WAS THE LATEX RETENSION CUFF ON A BARIUM ENEMA TIP. MEDICAL INTERVENTION WAS REQUIRED INCLUDING THE INJECTION OF EPINEPHRINE, SOLU-CORTEF, BENADRYL AND OXYGEN. AFTER TREATMENT PATIENT IMPROVED AND WAS HELD FOR OBSERVATION FOR ABOUT SIX HOURS BEFORE BEING DISCHARGED TOHOME. (E_Z_EM BAROSPERSE BARIUM & BAG WERE USED IN CONJUNCTION WITH ENEMA TIP. PRODUCT WAS NOT LABELED AS TO CONTENTS OR CONTRAINDICATIONSDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: LABELING - INCOMPLETE, UNANTICIPATED ADVERSE REACTION - SHORT TERM. CONCLUSION: OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS DESTROYED/DISPOSED OF.