SUR-FIT NATURA 401514Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00768455103362), received between Apr 5, 2024 and Apr 5, 2024 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048594 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048593 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048592 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048591 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048590 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048589 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048588 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048587 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048586 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048585 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048584 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048583 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048578 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048577 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048576 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048555 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048552 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048551 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048550 ↗
• MalfunctionApr 5, 2024Sharp Edges; Sharp Edges

  THE CONSUMER REPORTED THAT THERE WERE SHARP PLASTIC EDGES ON THE PLASTIC FLANGE RING. WHEN THE END USER ATTEMPTED TO USE TWO OF THE POUCHES OUT OF ONE BOX, IT RESULTED IN SCRATCHING HER FINGERS. ALSO, BECAUSE OF THE ISSUE, THEY WOULD NOT CONNECT TO THE WAFER. SHE DENIED BLEEDING. SHE VISUALLY INSPECTED THE REMAINING EIGHT IN THE BOX AND ALL TEN POUCHES IN THE SECOND BOX WITH THE SAME OBSERVATION. SHE DID NOT USE THE REMAINING POUCHES AND WAS ADVISED AGAINST IT. SHE HAD USED THE SAME PRODUCT FOR TWENTY YEARS AND DECLINED THE OFFER OF OTHER SAMPLES. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion

  MAUDE report 19048549 ↗