DAMON CUNITI W/STOPS .014X.025 PK10

Description of Event or Problem

IT WAS REPORTED A PATIENT SWALLOWED CLIPS WHEN THE ARCH WIRE BROKE. AFTER SWALLOWING PATIENT HAS A PAIN IN THE ESOPHAGUS. THE PRODUCT PASS THROUGH NATURALLY. IN DOCTOR'S OPINION WOULD IT LIKELY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY BECAUSE COULD POSSIBLE INJURY TO THE GASTROINTESTINAL TRACT OR ASPIRATION. PATIENT SEEK MEDICAL ATTENTION WITH A RADIOLOGIST, WAS DIAGNOSIS WITH A FOREIGN BODY IN THE COLON AFTER A X-RAY GASTROINTESTINAL TRACT. PATIENT IS FULLY RECOVERED.

Additional Manufacturer Narrative

THE RETAIN LOT NUMBER WAS NOT AVAILABLE IN THE WAREHOUSE AS THE PRODUCT WAS MANUFACTURED IN 2019. RETAIN SAMPLES FROM 2019 WERE UNAVAILABLE IN COMPLIANCE WITH DC MP 16-10.