SYMATESE, FSN-HEM/PAN-21-001-V2, PANGEN® and HEMOTESE®

Several complaints have been registered by SYMATESE following a difficulty encountered when opening the external pouch of haemostatic compresses similar to HEMOTESE®, with the same packaging as the HEMOTESE® product (See Appendix 1 –  presentation of the defect). The defect concerns the outer pouch, which may tear at the opening. This defect may induce difficulty in extracting the inner pouch containing the haemostatic compress. It is also possible that the opening of the outer pouch may not be possible when the strip delaminates, which may require the user to open another compress.