DR COMFORT

Additional Manufacturer Narrative

IT WAS REPORTED THAT WHILE THE PATIENT WAS WEARING THE SHOE BEGAN TO EXPERIENCE DISCOMFORT IN THE BIG TOE AREA OF HIS RIGHT FOOT, ESPECIALLY WHEN PRESSURE WAS APPLIED TO THE TOE IN THE COURSE OF HIS WORK. THE DISCOMFORT BECAME PAINFUL AND THEN THE PATIENT OBSERVED BLEEDING FROM THE TOE. ON (B)(6) 2021, THE PATIENT WENT TO HIS PODIATRIST WHO IDENTIFIED AN INJURY WHICH INCLUDED TWO SIGNIFICANT LACERATIONS ON THE BOTTOM OF THE PATIENTS FOOT. UPON EXAMINING THE DR. COMFORT WINNER X SHOE BEFORE THE PATIENTS NEXT VISIT, THE PATIENT DISCOVERED A BLADE OF AN X-ACTO KNIFE EMBEDDED IN THE SOLE OF THE SHOE AND THE EDGE BEGAN PROTRUDING THROUGH THE INSERT INTO THE PATIENTS TOE. CUSTOMER BELIEVES THAT THE PRESENCE IF THE X-ACTO KNIFE BLADE IN THE SOLE WAS A MANUFACTURING DEFECT. THE SHOE HAS NOT BEEN RETURNED FOR EVALUATION THE ROOT CAUSE COUD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT WHILE THE PATIENT WAS WEARING THE SHOE BEGAN TO EXPERIENCE DISCOMFORT IN THE BIG TOE AREA OF HIS RIGHT FOOT, ESPECIALLY WHEN PRESSURE WAS APPLIED TO THE TOE IN THE COURSE OF HIS WORK. THE DISCOMFORT BECAME PAINFUL AND THEN THE PATIENT OBSERVED BLEEDING FROM THE TOE. ON (B)(6) 2021, THE PATIENT WENT TO HIS PODIATRIST WHO IDENTIFIED AN INJURY WHICH INCLUDED TWO SIGNIFICANT LACERATIONS ON THE BOTTOM OF THE PATIENTS FOOT. UPON EXAMINING THE DR. COMFORT WINNER X SHOE BEFORE THE PATIENTS NEXT VISIT, THE PATIENT DISCOVERED A BLADE OF AN X-ACTO KNIFE EMBEDDED IN THE SOLE OF THE SHOE AND THE EDGE BEGAN PROTRUDING THROUGH THE INSERT INTO THE PATIENTS TOE. CUSTOMER BELIEVES THAT THE PRESENCE IF THE X-ACTO KNIFE BLADE IN THE SOLE WAS A MANUFACTURING DEFECT.

Additional Manufacturer Narrative

IT WAS REPORTED THAT WHILE THE PATIENT WAS WEARING THE SHOE BEGAN TO EXPERIENCE DISCOMFORT IN THE BIG TOE AREA OF HIS RIGHT FOOT, ESPECIALLY WHEN PRESSURE WAS APPLIED TO THE TOE IN THE COURSE OF HIS WORK. THE DISCOMFORT BECAME PAINFUL AND THEN THE PATIENT OBSERVED BLEEDING FROM THE TOE. ON (B)(6) 2021, THE PATIENT WENT TO HIS PODIATRIST WHO IDENTIFIED AN INJURY WHICH INCLUDED TWO SIGNIFICANT LACERATIONS ON THE BOTTOM OF THE PATIENTS FOOT. UPON EXAMINING THE DR. COMFORT WINNER X SHOE BEFORE THE PATIENTS NEXT VISIT, THE PATIENT DISCOVERED A BLADE OF AN X-ACTO KNIFE EMBEDDED IN THE SOLE OF THE SHOE AND THE EDGE BEGAN PROTRUDING THROUGH THE INSERT INTO THE PATIENTS TOE. CUSTOMER BELIEVES THAT THE PRESENCE IF THE X-ACTO KNIFE BLADE IN THE SOLE WAS A MANUFACTURING DEFECT. RETURNED PRODUCT INSPECTED, IT WAS NOTICED THE BLUE FILLER HAD THE PATTERN OF THE GEL INSERTS (INSERTS DESIGN ON BOTTOM OF INSERT) WHICH INDICATES THE CLIENT WORE THE BLUE FILLER AND THE GEL INSERTS. THE GEL INSERTS ARE THE ACTUAL INSERTS TO BE WORN WITH THE SHOE. IT WAS ALSO NOTED THAT THE KNIFE LOCATED IN THE SHOE IS NOT ONE THAT WOULD EVER BE USED IN OUR OPERATIONS FACILITY. THIS KNIFE LOOKS LIKE A SURGICAL KNIFE THAT IS NOT A TOOL USED IN ANY OF OUR PROCESSES OF SHIPPING. NONE OF OUR SUPPLIERS USE THIS TYPE OF TOOLING. SOME TYPE OF SUBSTANCE ON THE BOTTOM OF THE GEL INSERTS, AND LOTS OF DEBRIS WAS DISCOVERED ON THE PRODUCT. INSERTION POINT FOR THE KNIFE WAS NOT LOCATED, ONLY NOTICED IT WAS PLACED INSIDE THE SPACE CUT-OUT OF THE BLUE FILLER. UNABLE TO NOT FIND WHERE THE KNIFE PENETRATED THROUGH THE OUTSOLE, OR THE GEL INSERT. FINALLY, WE CANNOT CONFIRM THAT THIS IS A MANUFACTURING DEFECT OR ERROR ON THE BEHALF OF DR. COMFORT. THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE CONFIRMED.