Eakin 839002Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00768455108732), received between Aug 2, 2023 and Jul 20, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 8, 2024Open, Classified

   On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.

   Z-3263-2024 · Root cause: Process control · FDA record ↗

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.

• MalfunctionJul 20, 2026Positioning Failure; Leak/Splash; Material Too Rigid or Stiff

  A FRIEND OF THE END USER REPORTED THAT THREE TO FOUR BARRIER RINGS FROM A BOX WERE FIRM AND DID NOT ADHERE PROPERLY TO THE SKIN. THE REPORTER ALSO STATED THAT FOUR ADDITIONAL UNOPENED BOXES FROM THE SAME LOT NUMBER WERE AVAILABLE. THERE WERE NO VISIBLE DIFFERENCES NOTED WITH THE PRODUCT; HOWEVER, WHEN ATTEMPTING TO MOLD THE BARRIER RINGS, THEY APPEARED MUCH FIRMER THAN TYPICAL. THE REPORTER DESCRIBED THE PRODUCT AS BRITTLE, REQUIRING SIGNIFICANT FORCE TO MOLD, AND STATED THAT IT DID NOT ADHERE WELL TO THE SKIN AFTER APPLICATION. THE REPORTER FURTHER STATED THAT WEAR TIME WAS REDUCED TO LESS THAN ONE DAY, WITH ONE OCCURRENCE RESULTING IN LEAKAGE AFTER APPROXIMATELY ONE HOUR OF WEAR. THE PRODUCT HAD BEEN STORED IN ITS ORIGINAL PACKAGING UNTIL USE, AND KEPT IN A COOL AREA AWAY FROM HEAT AND HUMIDITY. REPLACEMENT PRODUCT WAS PROVIDED. NO HARM OR INJURY WAS REPORTED. NO PHOTOGRAPHS WERE AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25874603 ↗
• MalfunctionJul 20, 2026Positioning Failure; Leak/Splash; Material Too Rigid or Stiff

  A FRIEND OF THE END USER REPORTED THAT THREE TO FOUR BARRIER RINGS FROM A BOX WERE FIRM AND DID NOT ADHERE PROPERLY TO THE SKIN. THE REPORTER ALSO STATED THAT FOUR ADDITIONAL UNOPENED BOXES FROM THE SAME LOT NUMBER WERE AVAILABLE. THERE WERE NO VISIBLE DIFFERENCES NOTED WITH THE PRODUCT; HOWEVER, WHEN ATTEMPTING TO MOLD THE BARRIER RINGS, THEY APPEARED MUCH FIRMER THAN TYPICAL. THE REPORTER DESCRIBED THE PRODUCT AS BRITTLE, REQUIRING SIGNIFICANT FORCE TO MOLD, AND STATED THAT IT DID NOT ADHERE WELL TO THE SKIN AFTER APPLICATION. THE REPORTER FURTHER STATED THAT WEAR TIME WAS REDUCED TO LESS THAN ONE DAY, WITH ONE OCCURRENCE RESULTING IN LEAKAGE AFTER APPROXIMATELY ONE HOUR OF WEAR. THE PRODUCT HAD BEEN STORED IN ITS ORIGINAL PACKAGING UNTIL USE, AND KEPT IN A COOL AREA AWAY FROM HEAT AND HUMIDITY. REPLACEMENT PRODUCT WAS PROVIDED. NO HARM OR INJURY WAS REPORTED. NO PHOTOGRAPHS WERE AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25874059 ↗
• MalfunctionJul 20, 2026Positioning Failure; Leak/Splash; Material Too Rigid or Stiff

  A FRIEND OF THE END USER REPORTED THAT THREE TO FOUR BARRIER RINGS FROM A BOX WERE FIRM AND DID NOT ADHERE PROPERLY TO THE SKIN. THE REPORTER ALSO STATED THAT FOUR ADDITIONAL UNOPENED BOXES FROM THE SAME LOT NUMBER WERE AVAILABLE. THERE WERE NO VISIBLE DIFFERENCES NOTED WITH THE PRODUCT; HOWEVER, WHEN ATTEMPTING TO MOLD THE BARRIER RINGS, THEY APPEARED MUCH FIRMER THAN TYPICAL. THE REPORTER DESCRIBED THE PRODUCT AS BRITTLE, REQUIRING SIGNIFICANT FORCE TO MOLD, AND STATED THAT IT DID NOT ADHERE WELL TO THE SKIN AFTER APPLICATION. THE REPORTER FURTHER STATED THAT WEAR TIME WAS REDUCED TO LESS THAN ONE DAY, WITH ONE OCCURRENCE RESULTING IN LEAKAGE AFTER APPROXIMATELY ONE HOUR OF WEAR. THE PRODUCT HAD BEEN STORED IN ITS ORIGINAL PACKAGING UNTIL USE, AND KEPT IN A COOL AREA AWAY FROM HEAT AND HUMIDITY. REPLACEMENT PRODUCT WAS PROVIDED. NO HARM OR INJURY WAS REPORTED. NO PHOTOGRAPHS WERE AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25874058 ↗
• MalfunctionJun 24, 2026Material Disintegration

  THE NURSE REPORTED THAT SEALS WERE DRIED OUT AND CRUMBLED BEFORE USE. CONSUMER HAD USED PREVIOUSLY (FOR SEVERAL YEARS). TRIED THREE WAFERS SO FAR FROM THE BOX. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25608259 ↗
• MalfunctionJun 24, 2026Material Disintegration

  THE NURSE REPORTED THAT SEALS WERE DRIED OUT AND CRUMBLED BEFORE USE. CONSUMER HAD USED PREVIOUSLY (FOR SEVERAL YEARS). TRIED THREE WAFERS SO FAR FROM THE BOX. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25608144 ↗
• MalfunctionJun 24, 2026Material Disintegration

  THE NURSE REPORTED THAT SEALS WERE DRIED OUT AND CRUMBLED BEFORE USE. CONSUMER HAD USED PREVIOUSLY (FOR SEVERAL YEARS). TRIED THREE WAFERS SO FAR FROM THE BOX. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25608139 ↗
• MalfunctionJan 20, 2025Melted; Material Protrusion/Extrusion; Melted; Material Protrusion/Extrusion

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190547 ↗
• MalfunctionJan 20, 2025Melted; Material Protrusion/Extrusion; Melted; Material Protrusion/Extrusion

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190546 ↗
• MalfunctionJan 20, 2025Melted; Material Protrusion/Extrusion; Melted; Material Protrusion/Extrusion

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190545 ↗
• MalfunctionJan 20, 2025Melted; Material Protrusion/Extrusion; Melted; Material Protrusion/Extrusion

  THE END USER MENTIONED THAT SHE HAD BEEN USING COMPANY'S STOMA SEAL SINCE 2016. SHE USUALLY GETS SEVEN DAYS WEAR TIME. HOWEVER, WITH THE LAST TWO BOXES, SHE HAD NOTICED THAT THE RING WAS MELTED AND GOT OVER THE STOMA WITHIN ONE DAY OF USE. AT THAT POINT, SHE HAD TO PICK OFF THE WAX THAT WAS COVERING THE OPENING IN THE STOMA (OS). FURTHERMORE, THE END USER STATED THAT WHEN THE WAX WAS COVERING THE OPENING IN THE STOMA (OS) SHE GOT LIQUID STOOL, AND ONCE THE WAX WAS REMOVED FROM THE OPENING IN THE STOMA (OS), THE STOOL WAS DARKER IN COLOR WHEN IT CAME OUT. SINCE SHE HAD MANUALLY REMOVED THE WAX, THE STOOL WAS THEN BACK TO ITS NORMAL COLOR AND WAS TOOTHPASTE IN CONSISTENCY AND THAT IT FELT WELL. SHE WAS NOW PUSHING ON THE RING WITH THE APPLIANCE ON, TO ENSURE IT WAS NOT COVERING THE OPENING IN THE STOMA (OS). HER STOMA WAS PROTRUDING WELL, AND SHE WAS USING ANOTHER COMPANY'S TWO-PIECE CONVEX APPLIANCE WITH THE COMPANY'S RING. A PERSONAL SUPPORT WORKER (PSW) CAME WEEKLY TO ASSIST WITH HER CHANGES. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190544 ↗
• MalfunctionJan 20, 2025Melted; Material Protrusion/Extrusion; Melted; Material Protrusion/Extrusion

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190543 ↗
• MalfunctionJan 20, 2025Melted; Material Protrusion/Extrusion; Melted; Material Protrusion/Extrusion

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190542 ↗
• MalfunctionJan 20, 2025Melted; Material Protrusion/Extrusion; Melted; Material Protrusion/Extrusion

  THE END USER MENTIONED THAT SHE HAD BEEN USING COMPANY'S STOMA SEAL SINCE 2016. SHE USUALLY GETS SEVEN DAYS WEAR TIME. HOWEVER, WITH THE LAST TWO BOXES, SHE HAD NOTICED THAT THE RING WAS MELTED AND GOT OVER THE STOMA WITHIN ONE DAY OF USE. AT THAT POINT, SHE HAD TO PICK OFF THE WAX THAT WAS COVERING THE OPENING IN THE STOMA (OS). FURTHERMORE, THE END USER STATED THAT WHEN THE WAX WAS COVERING THE OPENING IN THE STOMA (OS) SHE GOT LIQUID STOOL, AND ONCE THE WAX WAS REMOVED FROM THE OPENING IN THE STOMA (OS), THE STOOL WAS DARKER IN COLOR WHEN IT CAME OUT. SINCE SHE HAD MANUALLY REMOVED THE WAX, THE STOOL WAS THEN BACK TO ITS NORMAL COLOR AND WAS TOOTHPASTE IN CONSISTENCY AND THAT IT FELT WELL. SHE WAS NOW PUSHING ON THE RING WITH THE APPLIANCE ON, TO ENSURE IT WAS NOT COVERING THE OPENING IN THE STOMA (OS). HER STOMA WAS PROTRUDING WELL, AND SHE WAS USING ANOTHER COMPANY'S TWO-PIECE CONVEX APPLIANCE WITH THE COMPANY'S RING. A PERSONAL SUPPORT WORKER (PSW) CAME WEEKLY TO ASSIST WITH HER CHANGES. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190541 ↗
• MalfunctionJan 20, 2025Melted; Material Protrusion/Extrusion; Melted; Material Protrusion/Extrusion

  THE END USER MENTIONED THAT SHE HAD BEEN USING COMPANY'S STOMA SEAL SINCE 2016. SHE USUALLY GETS SEVEN DAYS WEAR TIME. HOWEVER, WITH THE LAST TWO BOXES, SHE HAD NOTICED THAT THE RING WAS MELTED AND GOT OVER THE STOMA WITHIN ONE DAY OF USE. AT THAT POINT, SHE HAD TO PICK OFF THE WAX THAT WAS COVERING THE OPENING IN THE STOMA (OS). FURTHERMORE, THE END USER STATED THAT WHEN THE WAX WAS COVERING THE OPENING IN THE STOMA (OS) SHE GOT LIQUID STOOL, AND ONCE THE WAX WAS REMOVED FROM THE OPENING IN THE STOMA (OS), THE STOOL WAS DARKER IN COLOR WHEN IT CAME OUT. SINCE SHE HAD MANUALLY REMOVED THE WAX, THE STOOL WAS THEN BACK TO ITS NORMAL COLOR AND WAS TOOTHPASTE IN CONSISTENCY AND THAT IT FELT WELL. SHE WAS NOW PUSHING ON THE RING WITH THE APPLIANCE ON, TO ENSURE IT WAS NOT COVERING THE OPENING IN THE STOMA (OS). HER STOMA WAS PROTRUDING WELL, AND SHE WAS USING ANOTHER COMPANY'S TWO-PIECE CONVEX APPLIANCE WITH THE COMPANY'S RING. A PERSONAL SUPPORT WORKER (PSW) CAME WEEKLY TO ASSIST WITH HER CHANGES. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190537 ↗
• MalfunctionJan 20, 2025Melted; Material Protrusion/Extrusion; Melted; Material Protrusion/Extrusion

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190536 ↗
• MalfunctionJan 20, 2025Melted; Material Protrusion/Extrusion; Melted; Material Protrusion/Extrusion

  THE END USER MENTIONED THAT SHE HAD BEEN USING COMPANY'S STOMA SEAL SINCE 2016. SHE USUALLY GETS SEVEN DAYS WEAR TIME. HOWEVER, WITH THE LAST TWO BOXES, SHE HAD NOTICED THAT THE RING WAS MELTED AND GOT OVER THE STOMA WITHIN ONE DAY OF USE. AT THAT POINT, SHE HAD TO PICK OFF THE WAX THAT WAS COVERING THE OPENING IN THE STOMA (OS). FURTHERMORE, THE END USER STATED THAT WHEN THE WAX WAS COVERING THE OPENING IN THE STOMA (OS) SHE GOT LIQUID STOOL, AND ONCE THE WAX WAS REMOVED FROM THE OPENING IN THE STOMA (OS), THE STOOL WAS DARKER IN COLOR WHEN IT CAME OUT. SINCE SHE HAD MANUALLY REMOVED THE WAX, THE STOOL WAS THEN BACK TO ITS NORMAL COLOR AND WAS TOOTHPASTE IN CONSISTENCY AND THAT IT FELT WELL. SHE WAS NOW PUSHING ON THE RING WITH THE APPLIANCE ON, TO ENSURE IT WAS NOT COVERING THE OPENING IN THE STOMA (OS). HER STOMA WAS PROTRUDING WELL, AND SHE WAS USING ANOTHER COMPANY'S TWO-PIECE CONVEX APPLIANCE WITH THE COMPANY'S RING. A PERSONAL SUPPORT WORKER (PSW) CAME WEEKLY TO ASSIST WITH HER CHANGES. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190535 ↗
• MalfunctionJan 20, 2025Melted; Material Protrusion/Extrusion; Melted; Material Protrusion/Extrusion

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190534 ↗
• MalfunctionJan 20, 2025Melted; Material Protrusion/Extrusion; Melted; Material Protrusion/Extrusion

  THE END USER MENTIONED THAT SHE HAD BEEN USING COMPANY'S STOMA SEAL SINCE 2016. SHE USUALLY GETS SEVEN DAYS WEAR TIME. HOWEVER, WITH THE LAST TWO BOXES, SHE HAD NOTICED THAT THE RING WAS MELTED AND GOT OVER THE STOMA WITHIN ONE DAY OF USE. AT THAT POINT, SHE HAD TO PICK OFF THE WAX THAT WAS COVERING THE OPENING IN THE STOMA (OS). FURTHERMORE, THE END USER STATED THAT WHEN THE WAX WAS COVERING THE OPENING IN THE STOMA (OS) SHE GOT LIQUID STOOL, AND ONCE THE WAX WAS REMOVED FROM THE OPENING IN THE STOMA (OS), THE STOOL WAS DARKER IN COLOR WHEN IT CAME OUT. SINCE SHE HAD MANUALLY REMOVED THE WAX, THE STOOL WAS THEN BACK TO ITS NORMAL COLOR AND WAS TOOTHPASTE IN CONSISTENCY AND THAT IT FELT WELL. SHE WAS NOW PUSHING ON THE RING WITH THE APPLIANCE ON, TO ENSURE IT WAS NOT COVERING THE OPENING IN THE STOMA (OS). HER STOMA WAS PROTRUDING WELL, AND SHE WAS USING ANOTHER COMPANY'S TWO-PIECE CONVEX APPLIANCE WITH THE COMPANY'S RING. A PERSONAL SUPPORT WORKER (PSW) CAME WEEKLY TO ASSIST WITH HER CHANGES. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190533 ↗
• MalfunctionJan 20, 2025Melted; Material Protrusion/Extrusion; Melted; Material Protrusion/Extrusion

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190532 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Dry Skin; Erythema; Fungal Infection; Hemorrhage/Blood Loss/Bleeding; Itching Sensation; Skin Infection; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 17441176 ↗