Description of Event or Problem · 1
CIRCUMCISION WAS PERFORMED BY A PHYSICIAN AT 11:10 A.M. ON 11/10/92 USING A 1.1 CM CIRCUMCISION BELL AND INSERT. SMALL AMOUNT OF BLEEDING POST PROCEDURE. PRESSURE APPLIED BY PHYSICIAN AND GAUZE APPLIED. DIAPER WAS CHECKED AT 1:00 AM WITH NO BLEEDING. BABY HAD NOT VOIDED. AT 2:08 PM BABY WAS WITH MOTHER. MOTHER CALLED FOR ASSISTANCE. DIAPER WAS SATURATED WITH DARK RED BLOOD. BLEEDING WAS NOTED FROM UNDER THE EDGE OF CIRCUMCISED FORESKIN, DORSAL SIDE OF PENIS. ADRENALINE CHLORIDE 1:10 SOLUTION WAS APPLIED TO 4 X 4 GAUZE AND PRESSURE APPLIED TO PENIS. THE PHYSICIAN WAS CALLED AT 2:14 PM. BLEEDING CONTINUED FROM UNDER SKIN, DORSAL SIDE OF PENIS. BLEEDING CEASED AT 2:18 PM. PENIS WRAPPED IN VASELINE GAUZE AND PEDIATRICIAN NOTIFIED. DIAPER WEIGHT OF SATURATED DIAPER EQUALED 130 CC'S OF BLOOD LOSS. (POSSIBLE BABY COULD HAVE VOIDED BUT BLOOD DID NOT LOOK DILUTED, DARK RED IN COLOR).AT 2:30 PM NO BLOOD NOTED. AT 2:40 PM SCANT AMOUNT OF BLEEDING NOTED FROM CIRCUMCISION. VASELINE GAUZE REAPPLIED. AT 3:30 PM SCANT AMOUNT OF BLOOD NOTED. NO FURTHER BLEEDING NOTED AFTER 3:30 PM. BABY WAS DISCHARGED IN AM OF FOLLOWING DAY.DEVICE 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.