Description of Event or Problem · 0
MY FAMILY MEMBER WAS ATTACKED AND WAS PUT ON A CELL HARVESTING DEVICE AND A FEW ULTA DEVICES (ONE FOR EACH LEG) IN 2014. THE WOUND PROCEDURE (USING STAPLES), THE INFLAMMATION REACTION (NOT LIMITED TO: RASH ON THE BACK, WOUND EXUDATE), AND THE HEALING (NOT LIMITED TO: MACERATION, METAL STAPLES THAT MAY HAVE BEEN UNDER THE WOUND DRESSING, INFLAMMATION, SKIN 'SHINING', AND METAL STAPLES THAT MAY HAVE BEEN UNDER THE DRESSING) HAVE ME CONCERNED WHILE REVIEWING MEDICAL RECORDS. WE'D LIKE A CUSTOMER RESPONSE OVER THE MEDICAL PROCEDURE USED, INCLUDING WHETHER STAPLES WERE APPROPRIATE IN THIS CASE KNOWING A DRESSING WAS GOING TO BE USED, AND IF THE INFECTION WOULD HAVE BEEN CONCERNING TO THE MEDICAL DEVICE TEAM. IN MY YEARS WORKING FOR THE COMPANY THAT MANUFACTURERS THESE DEVICES, THIS HAS ALWAYS BEEN A CONCERNING WOUND CASE, AND I DON'T REMEMBER HEARING ABOUT IT - HOW THE COMPANY HAS VIEWED CASE STUDIES (IF THERE WAS ONE), HOW THE COMPANY TREATS INFECTIONS AND MACERATION, AND HOW THERE HAVE NOT BEEN ANY SKIN COMPLAINTS THAT I HAVE SEEN ABOUT CELLUTOME. ONLY ABOUT THE HARVESTERS FROM OTHER COUNTRIES. I'D LIKE A CUSTOMER RESPONSE ABOUT WHETHER THAT WOUND WAS HEALING APPROPRIATELY FROM THE HARVESTER, AND IF THE CELLS TRANSFERRED TO THE WOUND CAUSED HARM. THE LEG WOUND WAS INFECTED AND MACERATED. WAS IT CELLUTOME HARVESTED CELLS, THE STAPLES, OR AN INFECTION UNDER THE DRESSING, OR OTHER AFTER INVESTIGATION? COMPLAINT (1/2 TO ADD MORE PHOTOS). PT CODES: 1932, 2033, 1812, 2075. DEVICE CODE: 4001. REF REPORT: MW5180278.