DEMEBOND

Additional Manufacturer Narrative

A COMPLETE REVIEW OF THE DHR RECORDS FOR THE FINISHED PRODUCT WAS CONDUCTED. DEMELCRYL SIZE 4-0, PRODUCT CODE G284020B0P. LOT NUMBER C222-14 WAS PACKAGED ON MARCH 14, 2014 AND LOT NUMBER E263-14 WAS PACKAGED ON APRIL 09, 2014. THE REVIEW OF THE DHRS DID NOT INDICATE ANY ISSUES DURING THE MANUFACTURING AND PACKAGING PROCESSES. ALL IN-PROCESS TESTS MET THEIR RESPECTIVE SPECIFICATIONS AND, IN ADDITION, THE IN-PROCESS AND FINAL PRODUCT INSPECTIONS MET THE ACCEPTANCE CRITERIA. THE REVIEW INDICATED THAT THE PRODUCTS WERE MADE TO MEET STANDARD PRODUCT SPECIFICATIONS WITH NO CHANGES/MODIFICATIONS TO THE STANDARD MANUFACTURING PROCESS. A REVIEW OF THE PACKAGING AQL (ACCEPTANCE QUALITY LIMITS) INSPECTIONS THAT WERE PERFORMED DURING THE PACKAGING OF THE PRODUCT WAS CONDUCTED. DEMETECH USED AN AQL PROCEDURE BASED ON ANSI TABLES. THE QUALITY PERSONNEL DID NOT FIND ANY DEFECTS. BASED ON OUR REVIEW OF THE SAMPLES' TENSILE STRENGTH, THE DATA AT THE TIME OF PRODUCT RELEASED SAMPLES TESTING DATA, THE TENSILE STRENGTH AND NEEDLE PULL MET ALL OF THE USP REQUIREMENTS FOR EACH LOT'S CORRESPONDING SUTURE SIZE REQUIREMENTS. DEMETECH DID NOT RECEIVE ANY SAMPLES FOR LOT NUMBERS C222-14 & E263-14. THIS INVESTIGATION CONCLUDED THAT THE QUALITY, STRENGTH, OR INTEGRITY OF THE PRODUCT WAS NOT AFFECTED.

Description of Event or Problem

ON (B)(6) 2016 (B)(4) NOTIFIED DEMETECH CORP THAT THE SUTURE HAS TENSILE STRENGTH IS NOT GUARANTEED, AFTER TWO WEEKS OF THE SURGERY THE WOUND UNBENT AND BREAKS EASILY DURING SURGERY WITH LOT NUMBERS C222-14 & E263-14, PRODUCT CODE G284020B0P.