SUR-FIT NATURA 125260Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00768455101733), received between Oct 6, 2021 and Oct 6, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2021Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE WAFERS BECAME HARD APPROXIMATELY 24 HOURS AFTER APPLICATION. THE OPENING SURROUNDING THE STOMA THEN FELT IT WAS SHARP AND PUT PRESSURE AROUND THE STOMA. ONCE THE WAFER WAS REMOVED, THE PAIN WOULD IMMEDIATELY GO AWAY. THERE WAS NO VISIBLE INJURY TO THE STOMA NOTED BUT SOME REDNESS WAS NOTED AT THE MUCOCUTANEOUS JUNCTION. THE REDNESS RESOLVED ON ITS OWN WITHOUT TREATMENT. SHE STATED THAT THIS OCCURRED WITH MOST OF THE LAST MARKET UNIT. FOR SKIN CARE THE END USER WAS CLEANSING WITH IVORY SOAP AND WAS ALSO USING ADAPT PASTE. THE PACKAGING WAS DISCARDED AND THE LOT NUMBER COULD NOT BE RETRIEVED. SHE FURTHER STATED THAT THIS WAS NOT OCCURRING WITH THE CURRENT MARKET UNIT AND CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Erythema

  MAUDE report 12583050 ↗
• MalfunctionOct 6, 2021Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE WAFERS BECAME HARD APPROXIMATELY 24 HOURS AFTER APPLICATION. THE OPENING SURROUNDING THE STOMA THEN FELT IT WAS SHARP AND PUT PRESSURE AROUND THE STOMA. ONCE THE WAFER WAS REMOVED, THE PAIN WOULD IMMEDIATELY GO AWAY. THERE WAS NO VISIBLE INJURY TO THE STOMA NOTED BUT SOME REDNESS WAS NOTED AT THE MUCOCUTANEOUS JUNCTION. THE REDNESS RESOLVED ON ITS OWN WITHOUT TREATMENT. SHE STATED THAT THIS OCCURRED WITH MOST OF THE LAST MARKET UNIT. FOR SKIN CARE THE END USER WAS CLEANSING WITH IVORY SOAP AND WAS ALSO USING ADAPT PASTE. THE PACKAGING WAS DISCARDED AND THE LOT NUMBER COULD NOT BE RETRIEVED. SHE FURTHER STATED THAT THIS WAS NOT OCCURRING WITH THE CURRENT MARKET UNIT AND CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Erythema

  MAUDE report 12583048 ↗
• MalfunctionOct 6, 2021Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE WAFERS BECAME HARD APPROXIMATELY 24 HOURS AFTER APPLICATION. THE OPENING SURROUNDING THE STOMA THEN FELT IT WAS SHARP AND PUT PRESSURE AROUND THE STOMA. ONCE THE WAFER WAS REMOVED, THE PAIN WOULD IMMEDIATELY GO AWAY. THERE WAS NO VISIBLE INJURY TO THE STOMA NOTED BUT SOME REDNESS WAS NOTED AT THE MUCOCUTANEOUS JUNCTION. THE REDNESS RESOLVED ON ITS OWN WITHOUT TREATMENT. SHE STATED THAT THIS OCCURRED WITH MOST OF THE LAST MARKET UNIT. FOR SKIN CARE THE END USER WAS CLEANSING WITH IVORY SOAP AND WAS ALSO USING ADAPT PASTE. THE PACKAGING WAS DISCARDED AND THE LOT NUMBER COULD NOT BE RETRIEVED. SHE FURTHER STATED THAT THIS WAS NOT OCCURRING WITH THE CURRENT MARKET UNIT AND CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Erythema

  MAUDE report 12583046 ↗
• MalfunctionOct 6, 2021Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE WAFERS BECAME HARD APPROXIMATELY 24 HOURS AFTER APPLICATION. THE OPENING SURROUNDING THE STOMA THEN FELT IT WAS SHARP AND PUT PRESSURE AROUND THE STOMA. ONCE THE WAFER WAS REMOVED, THE PAIN WOULD IMMEDIATELY GO AWAY. THERE WAS NO VISIBLE INJURY TO THE STOMA NOTED BUT SOME REDNESS WAS NOTED AT THE MUCOCUTANEOUS JUNCTION. THE REDNESS RESOLVED ON ITS OWN WITHOUT TREATMENT. SHE STATED THAT THIS OCCURRED WITH MOST OF THE LAST MARKET UNIT. FOR SKIN CARE THE END USER WAS CLEANSING WITH IVORY SOAP AND WAS ALSO USING ADAPT PASTE. THE PACKAGING WAS DISCARDED AND THE LOT NUMBER COULD NOT BE RETRIEVED. SHE FURTHER STATED THAT THIS WAS NOT OCCURRING WITH THE CURRENT MARKET UNIT AND CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Erythema

  MAUDE report 12583045 ↗
• MalfunctionOct 6, 2021Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE WAFERS BECAME HARD APPROXIMATELY 24 HOURS AFTER APPLICATION. THE OPENING SURROUNDING THE STOMA THEN FELT IT WAS SHARP AND PUT PRESSURE AROUND THE STOMA. ONCE THE WAFER WAS REMOVED, THE PAIN WOULD IMMEDIATELY GO AWAY. THERE WAS NO VISIBLE INJURY TO THE STOMA NOTED BUT SOME REDNESS WAS NOTED AT THE MUCOCUTANEOUS JUNCTION. THE REDNESS RESOLVED ON ITS OWN WITHOUT TREATMENT. SHE STATED THAT THIS OCCURRED WITH MOST OF THE LAST MARKET UNIT. FOR SKIN CARE THE END USER WAS CLEANSING WITH IVORY SOAP AND WAS ALSO USING ADAPT PASTE. THE PACKAGING WAS DISCARDED AND THE LOT NUMBER COULD NOT BE RETRIEVED. SHE FURTHER STATED THAT THIS WAS NOT OCCURRING WITH THE CURRENT MARKET UNIT AND CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Erythema

  MAUDE report 12583044 ↗
• MalfunctionOct 6, 2021Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE WAFERS BECAME HARD APPROXIMATELY 24 HOURS AFTER APPLICATION. THE OPENING SURROUNDING THE STOMA THEN FELT IT WAS SHARP AND PUT PRESSURE AROUND THE STOMA. ONCE THE WAFER WAS REMOVED, THE PAIN WOULD IMMEDIATELY GO AWAY. THERE WAS NO VISIBLE INJURY TO THE STOMA NOTED BUT SOME REDNESS WAS NOTED AT THE MUCOCUTANEOUS JUNCTION. THE REDNESS RESOLVED ON ITS OWN WITHOUT TREATMENT. SHE STATED THAT THIS OCCURRED WITH MOST OF THE LAST MARKET UNIT. FOR SKIN CARE THE END USER WAS CLEANSING WITH IVORY SOAP AND WAS ALSO USING ADAPT PASTE. THE PACKAGING WAS DISCARDED AND THE LOT NUMBER COULD NOT BE RETRIEVED. SHE FURTHER STATED THAT THIS WAS NOT OCCURRING WITH THE CURRENT MARKET UNIT AND CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Erythema

  MAUDE report 12583043 ↗
• MalfunctionOct 6, 2021Sharp Edges; Sharp Edges

  THIS EMDR IS FOR AN ADDITIONAL UNKNOWN QUANTITY OF AFFECTED WAFERS FROM THE SAME MARKET UNIT. IT WAS REPORTED THAT THE WAFERS BECAME HARD APPROXIMATELY 24 HOURS AFTER APPLICATION. THE OPENING SURROUNDING THE STOMA THEN FELT IT WAS SHARP AND PUT PRESSURE AROUND THE STOMA. ONCE THE WAFER WAS REMOVED, THE PAIN WOULD IMMEDIATELY GO AWAY. THERE WAS NO VISIBLE INJURY TO THE STOMA NOTED BUT SOME REDNESS WAS NOTED AT THE MUCOCUTANEOUS JUNCTION. THE REDNESS RESOLVED ON ITS OWN WITHOUT TREATMENT. SHE STATED THAT THIS OCCURRED WITH MOST OF THE LAST MARKET UNIT. FOR SKIN CARE THE END USER WAS CLEANSING WITH IVORY SOAP AND WAS ALSO USING ADAPT PASTE. THE PACKAGING WAS DISCARDED AND THE LOT NUMBER COULD NOT BE RETRIEVED. SHE FURTHER STATED THAT THIS WAS NOT OCCURRING WITH THE CURRENT MARKET UNIT AND CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Erythema

  MAUDE report 12583038 ↗