FLYTE HOOD

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. SUPPLEMENTAL RATIONALE CORRECTED DATA: B5, H6, H11 6 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 5 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 1 DEVICE WAS EVALUATED USING DATA PROVIDED BY THE USER OR A THIRD PARTY.

Description of Event or Problem

THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. - 5 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT.

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 6 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 5 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION: 6 DEVICES WERE LABELED FOR SINGLE-USE. 6 DEVICES WERE NOT REPROCESSED OR REUSED.

Description of Event or Problem

THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. 6 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.