FLOSEAL

Description of Event or Problem

THE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WHEREIN FLOSEAL HEMOSTATIC MATRIX VH S/D, 5 ML WAS APPLIED. THE PATIENT DEVELOPED AN "UNEXPLAINED" POST OPERATIVE INFECTION (NOT FURTHER SPECIFIED). IT WAS NOT REPORTED IF ANY MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

D4: UNIQUE IDENTIFIER (UDI) #: IS NOT AVAILABLE FOR THE PRODUCT REPORTED IN THIS MEDICAL DEVICE REPORT. THIS PRODUCT CODE IS SOLD/DISTRIBUTED OUTSIDE THE US AND IS DEEMED SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED IN THE US; THEREFORE, THERE IS NO UNIQUE IDENTIFIER (UDI) FOR THIS PRODUCT. E1: INITIAL REPORTER POSTAL CODE: (B)(6). G1: DEVICE MANUFACTURER POSTAL CODE: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6 AND H11. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.