SUR-FIT NATURA 413185Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00768455106455), received between Apr 18, 2019 and Aug 1, 2022 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (20 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS EMDR IS BEING SUBMITTED FOR AN UNKNOWN NUMBER OF WAFERS FROM UNKNOWN NUMBER OF BOXES. THE CONSUMER REPORTED DEVELOPMENT OF A PERISTOMAL ULCER ABOUT FIVE WEEKS AGO. THE CONSUMER WHO ORIGINALLY CALLED COMPANY TO FIND THE ALTERNATIVE TO ANOTHER COMPANY'S WOUND DRESSING TO ORDER FOR A TREATMENT PLAN DERIVED BY A LOCAL WOUND CENTER WHICH HE HAD SCHEDULED FOLLOW-UPS NOW WEEKLY FOR A PERISTOMAL ULCER. UPON INVESTIGATION, HE STATED THE OPEN AREA DEVELOPED ALL OF A SUDDEN WITH THE TOP LAYER OF SKIN REMOVED ABOUT FIVE WEEKS AGO. HE REPORTED IT WAS LOCATED NEXT TO THE STOMA BENEATH WAFER ON THE RIGHT LOWER SIDE ABOUT THE SEVEN O'CLOCK POSITION AND WAS ABOUT THE SIZE OF A QUARTER AND ONE-FOURTH INCH IN DEPTH. HE REPORTED THE TISSUE WAS RED WITH SOME DRAINAGE. HE ALSO REPORTED THAT HE HAD BEEN SEEN BY A LOCAL WOUND CARE CENTER FOR SEVERAL WEEKS AND THEY WERE TREATING IT WITH GENTAMYCIN OINTMENT 0.1 % CREAM, COMPANY¿S DRESSING AND HYDROCOLLOID COVER EVERY THREE DAYS WITH APPLIANCE CHANGE. THE CONSUMER SHARED THAT HE HAS BEEN USING CONVEX PRECUT WAFER FOR MANY YEARS AND HAD NEVER EXPERIENCED THIS PREVIOUSLY. HE REPORTED AN AVERAGE APPLIANCE WEAR TIME OF FIVE-SEVEN DAYS PRIOR TO ULCERATION AN

  Patient problems: Erythema; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown; Ulcer

  MAUDE report 15137529 ↗
• MalfunctionAug 21, 2020Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435965 ↗
• MalfunctionAug 21, 2020Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435964 ↗
• MalfunctionAug 21, 2020Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435962 ↗
• MalfunctionAug 21, 2020Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435961 ↗
• MalfunctionAug 21, 2020Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435960 ↗
• MalfunctionAug 21, 2020Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435958 ↗
• MalfunctionAug 21, 2020Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435948 ↗
• MalfunctionAug 21, 2020Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435947 ↗
• MalfunctionAug 21, 2020Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435946 ↗
• MalfunctionAug 21, 2020Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435944 ↗
• MalfunctionApr 18, 2019Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527134 ↗
• MalfunctionApr 18, 2019Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527133 ↗
• MalfunctionApr 18, 2019Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527066 ↗
• MalfunctionApr 18, 2019Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527063 ↗
• MalfunctionApr 18, 2019Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527062 ↗
• MalfunctionApr 18, 2019Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527027 ↗
• MalfunctionApr 18, 2019Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527026 ↗
• MalfunctionApr 18, 2019Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527024 ↗
• MalfunctionApr 18, 2019Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527022 ↗
• MalfunctionApr 18, 2019Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8526977 ↗