D
Patient 1
ADDITIONAL INFO RECEIVED FROM MFR ON 03/17/1998: ON FEB 13. 1998, CO RECEIVED A REPORT REGARDING A COMPLAINT ON ONE OF THEIR PRODUCTS THROUGH FDA. THE NATURE OF THE REPORT CONTAINED COMPLAINTS FROM THE CONSUMER/ PATIENT WHO WAS USING THE PRODUCT AT THE TIME THE PRODUCT FAILED. AFTER INVESTIGATING THE CONTENT OF THE COMPLAINT REPORT AND CO RECORDS OF THE COMPLAINT, CO FELT THAT THEY DID NOT NEED TO REPORT THE EVENT UNDER THE MDR REQUIREMENTS BECAUSE NO DEATH, SERIOUS INJURY, OR MALFUNCTION OCCURRED. AS STATED IN THE CONTENT OF THE COMPLAINT, THE PT WAS ABLE TO RETURN TO HIS DESTINATION USING CRUTCHES, WHICH SHOWED NO SERIOUS INJURY. FURTHERMORE, THE PRODUCT DID NOT MALFUNCTION BUT RATHER WAS IMPROPERLY USED WHICH LEAD TO PREMATURE FAILURE. CO HAS HAD 3 BROKEN PARTS COME BACK FROM USERS ON THIS PARTICULAR PART, INCLUDING THE LATEST, BUT IN EACH CASE OF THE INSTANCES, CO FOUND OUT THAT THE PART BROKE DUE TO IMPROPER APPLICATION. NO INJURIES OCCURRED FROM EACH OF THE INCIDENTS. HOWEVER, WHEN CO'S RESEARCH ENGINEER, WHO IS A RECENT HIRE, SPOKE W/ THE PT ON THIS MATTER, THE ENGINEER TOLD THE PT CO HAD HAD PROBLEMS W/ THE PART NOT EXPLAINING THE FACT THAT THE FAILURES CAME FROM IMPROPER USE BECAUSE HE DID NOT KNOW THE BACK GROUNG ON THIS SUBJECT MATTER. THE ENGINEER JUST ASSUMED THAT THE PART HAD A DESIGN PROBLEM AND DID NOT KNOW THAT THE PART WAS BEING USED IMPROPERLY. SO CO. REP. CALLED THE PT AND CLARIFIED WITH HIM THAT CO DID NOT HAVE ANY FAILURES ON THE PART WHEN USED PROPERLY. THE PT WAS ALSO TOLD THAT THE CO WILL FILE THIS INCIDENT IN THEIR FDA FILE, WHICH IS WHAT CO REFERS TO FOR ANY DOCUMENTS WHICH ARE FILED FOR CORRECTIVE ACTIONS AND REGULATORY PURPOSES. HOWEVER, THE PT MUST HAVE THOUGHT THAT CO WAS GOING TO FILE THE REPORT TO THE FDA ABOUT THE INCIDENT. IN RESPONSE TO THE INCIDENT, CO DECIDED TO ELIMINATE ANY FUTURE PROBLEMS OF IMPROPER APPLICATION BY ADDING LABELS ON PACKAGING WHICH STATES PROPER APPLICATION OF THE PRODUCT. THIS IS ADDED IN ADDITION TO THE PRODUCT INSTRUCTION WHICH ALREADY STATES HOW THE PART SHOULD BE USED. FURTHERMORE, CO DECIDED TO CHANGE THE DESIGN SO THAT IT IS IMPOSSIBLE FOR ANYONE TO USE THE PART IMPROPERLY.FOR NOW, CO FEELS THAT EXISTING PARTS CAN BE SOLD IN ITS FORM, GIVEN THAT CO HAS ADDED WARNING LABELS TO THE PACKAGING.