GOMCO

Additional Manufacturer Narrative

A COMPLAINT WAS RECEIVED INVOLVING A CIRCUMCISION CLAMP THAT REPORTEDLY CAUSED A SMALL CUT TO THE FORESKIN DURING USE. NO LONG-TERM COMPLICATIONS OR SERIOUS INJURY HAVE BEEN REPORTED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. FOLLOW-UP ACTIVITIES ARE ONGOING TO OBTAIN THE DEVICE AND ADDITIONAL INFORMATION RELATED TO THE EVENT.

Description of Event or Problem

I RECENTLY ORDERED 5 NEW GOMCO 1.1 CIRCUMCISION DEVICES AT THE END OF (B)(6). THEY WERE PLACED IN ROTATION LAST WEEK AND I HAD A PHYSICIAN TO USE TWO OF THEM AND REPORTED THAT BOTH TIMES, THE DEVICE CAUSED A SMALL CUT TO THE FORESKIN WHILE IN USE.