CARD,LOAD RECORD,STERILIZATION

Additional Manufacturer Narrative

THE CUSTOMER REPORTED AN INFECTION. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. THE SAMPLE WAS REQUESTED TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

REPORTED INFECTION DUE TO STERILIZATION INDICATOR.

Additional Manufacturer Narrative

UPDATED WITH INFORMATION GATHERED DUE TO SAMPLE BEING RETURNED. LOT NUMBER AND SAMPLE INFORMATION WAS UPDATED.