SUR-FIT NATURA 421034Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00768455133086), received between Nov 7, 2018 and Jun 4, 2026 — classified as 53 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (53 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25390309 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25390308 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25390306 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25390218 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25390215 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25390213 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25390212 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25390211 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25389671 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25389667 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25389666 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25389665 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25389664 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25389663 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25389661 ↗
• MalfunctionJun 4, 2026Malposition of Device

  THE END USER CALLED TO REPORT THAT THE LAST TWO BOXES SHE HAD RECEIVED CONTAINED PRODUCTS WITH OFF-CENTERED STARTER HOLES. SHE EXPLAINED THAT THIS ISSUE HAD LED TO PREMATURE LEAKAGE, REQUIRING HER TO CHANGE THE PRODUCT ONCE TO TWICE DAILY INSTEAD OF HER USUAL WEAR TIME OF THREE TO FOUR DAYS. DUE TO THESE MORE FREQUENT CHANGES, SHE REPORTED EXPERIENCING SKIN IRRITATION AND BLEEDING. SHE STATED THAT SHE WOULD CONTINUE TO MONITOR HER SKIN CONDITION, AND IT WAS DISCUSSED THAT SHE SHOULD CONSIDER CONTACTING AN NURSE SPECIALIZED IN WOUND, OSTOMY, AND CONTINENCE (NSWOC) IF HER SKIN DID NOT IMPROVE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 25389588 ↗
• MalfunctionMay 8, 2023Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  THE END USER REPORTED THAT THE TEN WAFERS FROM ONE MARKET UNIT HAD OFF CENTERED STARTER HOLE PRIOR TO USE. FURTHER, MENTIONED THAT HE DID NOT USE MOST OF THE WAFERS BUT HAD TO USE THE ONES LESS AFFECTED. HE ALSO REPORTED DECREASED WEAR TIME.  HE STATED THAT HIS NORMAL WEAR TIME WAS ONE MONTH AND WITH THOSE THAT WERE OFF CENTERED, IT WAS LESS THAN THAT A WEEK OR LESS. THERE WAS NO HARM REPORTED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16884224 ↗
• MalfunctionMay 8, 2023Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16884221 ↗
• MalfunctionMay 8, 2023Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16884220 ↗
• MalfunctionMay 8, 2023Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  THE END USER REPORTED THAT THE TEN WAFERS FROM ONE MARKET UNIT HAD OFF CENTERED STARTER HOLE PRIOR TO USE. FURTHER, MENTIONED THAT HE DID NOT USE MOST OF THE WAFERS BUT HAD TO USE THE ONES LESS AFFECTED. HE ALSO REPORTED DECREASED WEAR TIME.  HE STATED THAT HIS NORMAL WEAR TIME WAS ONE MONTH AND WITH THOSE THAT WERE OFF CENTERED, IT WAS LESS THAN THAT A WEEK OR LESS. THERE WAS NO HARM REPORTED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16884219 ↗
• MalfunctionMay 8, 2023Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  THE END USER REPORTED THAT THE TEN WAFERS FROM ONE MARKET UNIT HAD OFF CENTERED STARTER HOLE PRIOR TO USE. FURTHER, MENTIONED THAT HE DID NOT USE MOST OF THE WAFERS BUT HAD TO USE THE ONES LESS AFFECTED. HE ALSO REPORTED DECREASED WEAR TIME.  HE STATED THAT HIS NORMAL WEAR TIME WAS ONE MONTH AND WITH THOSE THAT WERE OFF CENTERED, IT WAS LESS THAN THAT A WEEK OR LESS. THERE WAS NO HARM REPORTED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16884216 ↗
• MalfunctionMay 8, 2023Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  THE END USER REPORTED THAT THE TEN WAFERS FROM ONE MARKET UNIT HAD OFF CENTERED STARTER HOLE PRIOR TO USE. FURTHER, MENTIONED THAT HE DID NOT USE MOST OF THE WAFERS BUT HAD TO USE THE ONES LESS AFFECTED. HE ALSO REPORTED DECREASED WEAR TIME.  HE STATED THAT HIS NORMAL WEAR TIME WAS ONE MONTH AND WITH THOSE THAT WERE OFF CENTERED, IT WAS LESS THAN THAT A WEEK OR LESS. THERE WAS NO HARM REPORTED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16884215 ↗
• MalfunctionMay 8, 2023Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  THE END USER REPORTED THAT THE TEN WAFERS FROM ONE MARKET UNIT HAD OFF CENTERED STARTER HOLE PRIOR TO USE. FURTHER, MENTIONED THAT HE DID NOT USE MOST OF THE WAFERS BUT HAD TO USE THE ONES LESS AFFECTED. HE ALSO REPORTED DECREASED WEAR TIME.  HE STATED THAT HIS NORMAL WEAR TIME WAS ONE MONTH AND WITH THOSE THAT WERE OFF CENTERED, IT WAS LESS THAN THAT A WEEK OR LESS. THERE WAS NO HARM REPORTED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16884213 ↗
• MalfunctionMay 8, 2023Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  THE END USER REPORTED THAT THE TEN WAFERS FROM ONE MARKET UNIT HAD OFF CENTERED STARTER HOLE PRIOR TO USE. FURTHER, MENTIONED THAT HE DID NOT USE MOST OF THE WAFERS BUT HAD TO USE THE ONES LESS AFFECTED. HE ALSO REPORTED DECREASED WEAR TIME.  HE STATED THAT HIS NORMAL WEAR TIME WAS ONE MONTH AND WITH THOSE THAT WERE OFF CENTERED, IT WAS LESS THAN THAT A WEEK OR LESS. THERE WAS NO HARM REPORTED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16884212 ↗
• MalfunctionMay 8, 2023Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  THE END USER REPORTED THAT THE TEN WAFERS FROM ONE MARKET UNIT HAD OFF CENTERED STARTER HOLE PRIOR TO USE. FURTHER, MENTIONED THAT HE DID NOT USE MOST OF THE WAFERS BUT HAD TO USE THE ONES LESS AFFECTED. HE ALSO REPORTED DECREASED WEAR TIME.  HE STATED THAT HIS NORMAL WEAR TIME WAS ONE MONTH AND WITH THOSE THAT WERE OFF CENTERED, IT WAS LESS THAN THAT A WEEK OR LESS. THERE WAS NO HARM REPORTED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16884211 ↗