N
Patient 1
NO SAMPLE OR LOT NUMBER INFO WAS PROVIDED FOR INVESTIGATION. NO POTENTIAL CAUSE OF THE REPORTED ISSUE WAS FOUND DURING THE IN-PROCESS REVIEW. A REVIEW OF THE INCOMING QUALITY ASSURANCE RECORDS DID NOT SHOW ANY REJECTS RELATED TO TENSILE VALUES. ALL VALUES WITHIN THE LAST TWO YEARS WERE ABOVE THOSE SPECIFIED IN THE INTERNATIONAL STANDARD FOR SURGICAL DRAINS. THERE WAS NO EVIDENCE OF ANY MANUFACTURING ISSUES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. A REVIEW OF THE INSTRUCTIONS FOR USE SHOWED THE FOLLOWING: CAUTIONS: TO AVOID THE POSSIBILTY OF DRAIN DAMAGE OR BREAKAGE: ADD'L PERFORATIONS SHOULD NOT BE MADE IN THE DRAINS. AVOID SUTURING THROUGH DRAINS. DRAINS SHOULD LIE FLAT AND IN LINE WITH THE SKIN EXIT AREAS. PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH. DRAINS SHOULD BE CHECKED DURING CLOSURE FOR FREE MOTION TO MINIMIZE THE POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. DRAINS SHOULD NOT BE HANDLED WITH POINTED, TOOTHED OR SHARP INSTRUMENTS WHICH COULD CAUSE CUTS OR NICKS AND LEAD TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN. WARNING: SURGICAL REMOVAL MAY BE NECESSARY IF DRAIN IS DIFFICULT TO REMOVE OR BREAKS. PRODUCT CODE GCY.