Eakin 839005Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00768455118250), received between Aug 13, 2026 and Aug 14, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Loss of or Failure to Bond; Positioning Failure; Material Too Rigid or Stiff

  The end user reported that company's cohesive seals were less pliable, firmer and less adhesive and more difficult for her to mold into place. She stated that the adhesive on them felt spotty. Furthermore, she mentioned that four out of two market units had the same lot number, that she used two seals at a time and tried two from each box and both felt the same. She referred that she had been using this product for over ten years and had never had a problem. She denied any changes to other accessory products or her pouching system. The user reported that she wore another brand pouch and stated that her normal wear time was four to five days, but with this shipment of our company's seals, her wear time had decreased to every two days. She stated that she did not want to use any more seals from these boxes. No photo was available at that time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252172 ↗
• MalfunctionAug 14, 2026Loss of or Failure to Bond; Positioning Failure; Material Too Rigid or Stiff

  The end user reported that company's cohesive seals were less pliable, firmer and less adhesive and more difficult for her to mold into place. She stated that the adhesive on them felt spotty. Furthermore, she mentioned that four out of two market units had the same lot number, that she used two seals at a time and tried two from each box and both felt the same. She referred that she had been using this product for over ten years and had never had a problem. She denied any changes to other accessory products or her pouching system. The user reported that she wore another brand pouch and stated that her normal wear time was four to five days, but with this shipment of our company's seals, her wear time had decreased to every two days. She stated that she did not want to use any more seals from these boxes. No photo was available at that time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252168 ↗
• MalfunctionAug 14, 2026Loss of or Failure to Bond; Positioning Failure; Material Too Rigid or Stiff

  The end user reported that company's cohesive seals were less pliable, firmer and less adhesive and more difficult for her to mold into place. She stated that the adhesive on them felt spotty. Furthermore, she mentioned that four out of two market units had the same lot number, that she used two seals at a time and tried two from each box and both felt the same. She referred that she had been using this product for over ten years and had never had a problem. She denied any changes to other accessory products or her pouching system. The user reported that she wore another brand pouch and stated that her normal wear time was four to five days, but with this shipment of our company's seals, her wear time had decreased to every two days. She stated that she did not want to use any more seals from these boxes. No photo was available at that time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252165 ↗
• MalfunctionAug 14, 2026Loss of or Failure to Bond; Positioning Failure; Material Too Rigid or Stiff

  The end user reported that company's cohesive seals were less pliable, firmer and less adhesive and more difficult for her to mold into place. She stated that the adhesive on them felt spotty. Furthermore, she mentioned that four out of two market units had the same lot number, that she used two seals at a time and tried two from each box and both felt the same. She referred that she had been using this product for over ten years and had never had a problem. She denied any changes to other accessory products or her pouching system. The user reported that she wore another brand pouch and stated that her normal wear time was four to five days, but with this shipment of our company's seals, her wear time had decreased to every two days. She stated that she did not want to use any more seals from these boxes. No photo was available at that time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252161 ↗
• MalfunctionAug 13, 2026Positioning Failure; Material Too Rigid or Stiff

  The consumer reported that the Eakin Cohesive Seals were less pliable and firmer than expected, making them more difficult to mold into place. She also stated that the adhesive felt spotty. The issue was observed in four units from two market boxes bearing the same lot number. The consumer stated that she used two Eakin Cohesive Seals at a time and had tried two seals from each box. She reported that all the seals felt the same and indicated that she did not wish to use any additional seals from the affected boxes. The consumer had been using the product for over ten years and stated that she had never previously experienced any problems. She denied any changes to her other accessory products or pouching system. She reported using a competitor pouch and stated that her typical wear time was four to five days. However, with the seals from the affected shipment, her wear time had decreased to approximately two days. She attributed the reduced wear time to the seals being less pliable and less adhesive than usual. No photographs are available at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50238941 ↗
• MalfunctionAug 13, 2026Positioning Failure; Material Too Rigid or Stiff

  The consumer reported that the Eakin Cohesive Seals were less pliable and firmer than expected, making them more difficult to mold into place. She also stated that the adhesive felt spotty. The issue was observed in four units from two market boxes bearing the same lot number. The consumer stated that she used two Eakin Cohesive Seals at a time and had tried two seals from each box. She reported that all the seals felt the same and indicated that she did not wish to use any additional seals from the affected boxes. The consumer had been using the product for over ten years and stated that she had never previously experienced any problems. She denied any changes to her other accessory products or pouching system. She reported using a competitor pouch and stated that her typical wear time was four to five days. However, with the seals from the affected shipment, her wear time had decreased to approximately two days. She attributed the reduced wear time to the seals being less pliable and less adhesive than usual. No photographs are available at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50238938 ↗
• MalfunctionAug 13, 2026Positioning Failure; Material Too Rigid or Stiff

  The consumer reported that the Eakin Cohesive Seals were less pliable and firmer than expected, making them more difficult to mold into place. She also stated that the adhesive felt spotty. The issue was observed in four units from two market boxes bearing the same lot number. The consumer stated that she used two Eakin Cohesive Seals at a time and had tried two seals from each box. She reported that all the seals felt the same and indicated that she did not wish to use any additional seals from the affected boxes. The consumer had been using the product for over ten years and stated that she had never previously experienced any problems. She denied any changes to her other accessory products or pouching system. She reported using a competitor pouch and stated that her typical wear time was four to five days. However, with the seals from the affected shipment, her wear time had decreased to approximately two days. She attributed the reduced wear time to the seals being less pliable and less adhesive than usual. No photographs are available at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50238935 ↗
• MalfunctionAug 13, 2026Positioning Failure; Material Too Rigid or Stiff

  The consumer reported that the Eakin Cohesive Seals were less pliable and firmer than expected, making them more difficult to mold into place. She also stated that the adhesive felt spotty. The issue was observed in four units from two market boxes bearing the same lot number. The consumer stated that she used two Eakin Cohesive Seals at a time and had tried two seals from each box. She reported that all the seals felt the same and indicated that she did not wish to use any additional seals from the affected boxes. The consumer had been using the product for over ten years and stated that she had never previously experienced any problems. She denied any changes to her other accessory products or pouching system. She reported using a competitor pouch and stated that her typical wear time was four to five days. However, with the seals from the affected shipment, her wear time had decreased to approximately two days. She attributed the reduced wear time to the seals being less pliable and less adhesive than usual. No photographs are available at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50238932 ↗