PLUGGER 1-2

Additional Manufacturer Narrative

ADDITIONAL INFORMATION RECEIVED : NO INJURY OCCURRED. ALL BROKENT PARTS WERE REMOVED FROM PATIENT'S MOUTH, NO FURTHER MEDICAL/SURGICAL TREATMENT NECESSARY. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: HEALTH EFFECT - CLINICAL CODE -4580. HEALTH EFFECT - IMPACT CODE - 4648. THE CORRECT CODES FOR THIS COMPLAINT ARE: HEALTH EFFECT - CLINICAL CODE - 4582. HEALTH EFFECT - IMPACT CODE - 2199.

Additional Manufacturer Narrative

THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW. NO PRODUCT AND NO LOT# AVAILABLE. NO INVESTIGATION OR DHR REVIEW CAN BE DONE. ROOT CAUSES ARE NOT DETERMINED. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT PLUGGER 1-2 BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.