SUR-FIT NATURA 421033Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00768455133079), received between Nov 17, 2020 and Jul 15, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2022Malposition of Device; Malposition of Device

  THE END USER REPORTED THAT MULTIPLE WAFERS HAD AN OFF CENTERED STARTER HOLE. HE WORE ONE AND FOUND TWO MORE IN THE BOX AND ALSO THOUGHT THAT HIS WIFE MIGHT HAVE FOUND MORE AND THOSE WAFERS WERE DISCARDED. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15025717 ↗
• MalfunctionJul 15, 2022Malposition of Device; Malposition of Device

  THE END USER REPORTED THAT MULTIPLE WAFERS HAD AN OFF CENTERED STARTER HOLE. HE WORE ONE AND FOUND TWO MORE IN THE BOX AND ALSO THOUGHT THAT HIS WIFE MIGHT HAVE FOUND MORE AND THOSE WAFERS WERE DISCARDED. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15025715 ↗
• MalfunctionJul 15, 2022Malposition of Device; Malposition of Device

  THE END USER REPORTED THAT MULTIPLE WAFERS HAD AN OFF CENTERED STARTER HOLE. HE WORE ONE AND FOUND TWO MORE IN THE BOX AND ALSO THOUGHT THAT HIS WIFE MIGHT HAVE FOUND MORE AND THOSE WAFERS WERE DISCARDED. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15025714 ↗
• MalfunctionJul 15, 2022Malposition of Device; Malposition of Device

  THIS EMDR IS CREATED FOR AN UNKNOWN QUANTITY OF WAFERS FROM THE MARKET UNIT BOX. THE END USER REPORTED THAT MULTIPLE WAFERS HAD AN OFF CENTERED STARTER HOLE. HE WORE ONE AND FOUND TWO MORE IN THE BOX AND ALSO THOUGHT THAT HIS WIFE MIGHT HAVE FOUND MORE AND THOSE WAFERS WERE DISCARDED. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15025713 ↗
• MalfunctionNov 17, 2020Material Disintegration; Material Separation; Material Disintegration; Material Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10850184 ↗
• MalfunctionNov 17, 2020Material Disintegration; Material Separation; Material Disintegration; Material Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10850183 ↗