ORS-100, WARMER DRAPE, 44" X 44"

Additional Manufacturer Narrative

THE DEFECTIVE DISPOSABLE DEVICE WAS NOT RETURNED TO ECOLAB-MICROTEK, THEREFORE, NO DIRECT ANALYSIS IS AVAILABLE. THERE WERE A FEW EMAILS AND PHONE CALLS FROM THE COMPLAINT DEPT OF ECOLAB-MICROTEK TO (B)(4) RISK MGMT DEPT REQUESTING MORE INFO. THE DHR WAS REVIEWED AND IT WAS SHOWN THAT THE LOT #D140221 HAD (B)(4) PIECES MANUFACTURED ON (B)(4) 2014. THERE WERE NO DEFECTS IN THE PROCESSES, PACKAGING OR FINAL INSPECTION (NOTE: THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS). SINCE NO DEVICE WAS RETURNED FOR ANALYSIS AND NO TREATMENT RECORDS WERE PROVIDED TO THE PATIENT, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE EVENT. INTERNAL REF: (B)(4).

Description of Event or Problem

ECOLAB-MICROTEK WAS NOTIFIED OF A MAUDE EVENT REPORT ((B)(4)) FROM THE FDA ON (B)(4) 2014. THERE WAS AN INCIDENT REPORTED STATING THAT AT THE END OF THE PROCEDURE AFTER THE SURGERY WAS COMPLETED AND THE ROOM HAD BEEN BROKEN DOWN, A HOLE WAS FOUND IN THE DRAPE. THE CAUSE OF THE HOLE IN THE DRAPE WAS NOT DEFECTED PRIOR TO THE SURGERY AND MAY HAVE OCCURRED DURING THE SURGERY DUE TO HEAT FROM THE EQUIPMENT. THE CAUSE OF THE DEFECTIVE DEVICE WAS NOT DETERMINED BY THE HOSP STAFF. THERE WAS NO PATIENT INJURY OR POST-OPERATIVE TREATMENT REPORTED. REF. VOLUNTARY REP: (B)(4).