TOROSA

Description of Event or Problem

SUBJECT: FORMAL COMPLAINT REGARDING PRODUCT SIZE AND AVAILABILITY DEAR MEDWATCH TEAM AT FDA, I AM WRITING TO EXPRESS MY DISSATISFACTION WITH THE COLOPLAST TOROSA BRAND PRODUCT, WHICH I RECEIVED AS PART OF A MEDICAL PROCEDURE. WHILE I UNDERSTAND THAT COLOPLAST IS THE ONLY TRUSTED PROVIDER OF FDA-APPROVED MEDICAL DEVICES FOR THIS TYPE, MY EXPERIENCE WITH THIS PRODUCT HAS LEFT ME DEEPLY CONCERNED ABOUT ITS DESIGN AND SUITABILITY FOR THE U.S. MARKET. SPECIFIC CONCERNS INADEQUATE SIZING: THE PRODUCT I RECEIVED APPEARS TO BE SIGNIFICANTLY SMALLER THAN WHAT WOULD BE APPROPRIATE FOR AN AVERAGE ADULT MALE ANATOMY. THIS DISCREPANCY HAS CAUSED PHYSICAL DISCOMFORT, WHICH I BELIEVE IS DIRECTLY RELATED TO THE SMALL SIZE OF THE IMPLANT. LACK OF ALTERNATIVES: UPON CONSULTING MY UROLOGIST, I WAS DISAPPOINTED TO LEARN THAT LARGER SIZES OR ALTERNATIVE OPTIONS ARE NOT AVAILABLE IN THE U.S. MARKET. BOTH MY UROLOGIST AND I WERE SURPRISED BY THE LIMITED SIZING OPTIONS PROVIDED BY COLOPLAST. INSUFFICIENT INFORMATION: I FACED SIGNIFICANT CHALLENGES OBTAINING DETAILED INFORMATION ABOUT THE PRODUCT FROM BOTH MY ORIGINAL SURGEON AND COLOPLAST. IT WAS ONLY THROUGH PERSISTENT EFFORT AND RESEARCH THAT I LEARNED OF THE SIZE LIMITATIONS. IMPACT ON MY HEALTH THE DISCOMFORT CAUSED BY THE PRODUCT PROMPTED ME TO SEEK MEDICAL ADVICE FROM ANOTHER UROLOGIST. AFTER EVALUATING THE IMPLANT, MY NEW HEALTHCARE PROVIDER AND I ARE CONCERNED ABOUT THE PRODUCT'S SUITABILITY FOR ITS INTENDED PURPOSE. THE CURRENT SIZE OPTIONS SEEM INADEQUATE TO ADDRESS THE NEEDS OF MANY PATIENTS, POTENTIALLY LEADING TO UNNECESSARY COMPLICATIONS AND DISSATISFACTION. REQUEST FOR RESOLUTION AS A CONSUMER, I BELIEVE IT IS COLOPLAST'S RESPONSIBILITY TO: PROVIDE ADEQUATE SIZING OPTIONS: EXPAND THE RANGE OF AVAILABLE SIZES TO BETTER ACCOMMODATE THE DIVERSE NEEDS OF PATIENTS. ENHANCE TRANSPARENCY: ENSURE THAT SURGEONS AND PATIENTS CAN EASILY ACCESS DETAILED INFORMATION ABOUT PRODUCT DIMENSIONS AND ALTERNATIVES. REVIEW PRODUCT DESIGN: CONDUCT A THOROUGH REVIEW TO DETERMINE WHETHER THE CURRENT DESIGN MEETS BOTH MEDICAL AND PHYSICAL STANDARDS FOR THE U.S. MARKET. I TRUST THAT COLOPLAST TAKES CUSTOMER FEEDBACK SERIOUSLY AND IS COMMITTED TO DELIVERING PRODUCTS THAT MEET THE HIGHEST STANDARDS OF QUALITY AND PATIENT CARE. I WOULD APPRECIATE A PROMPT RESPONSE TO THIS LETTER, INCLUDING INFORMATION ON ANY PLANS TO ADDRESS THE CONCERNS RAISED. THANK YOU FOR YOUR ATTENTION TO THIS MATTER. PLEASE FEEL FREE TO CONTACT ME TO DISCUSS THIS ISSUE FURTHER. SINCERELY, (B)(6).