ACTIVELIFE 175782Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00768455102563), received between Sep 17, 2020 and Sep 17, 2020 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (19 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545634 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545633 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545632 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545631 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545592 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545591 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545590 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545589 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545587 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545585 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545584 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545582 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545560 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545557 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545556 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545451 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THIS EMDR IS FOR AN ADDITIONAL UNKNOWN QUANTITY OF AFFECTED WAFERS. THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545350 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545348 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  THE END USER ESTIMATED ABOUT 3 POUCHES FROM EACH OF THE 6 MARKET UNITS THAT WERE AFFECTED. THE PRECUT OPENING IN THE CONVEX MASS WAS VERY OFF CENTERED. SHE STATED THAT THE OFF CENTERED BARRIER HAD CAUSED HER TO DEVELOP AN OPEN SORE AT THE 9 O'CLOCK POSITION, APPROXIMATELY 13 X 25MM WITH SOME BLEEDING. HER WEAR TIME WAS 3 DAYS. REPORTEDLY, SHE HAD BEEN SEEN BY A LOCAL OSTOMY NURSE. SHE WAS WEARING A HERNIA BELT, BUT RECENTLY STOPPED USING THE BELT. SHE FURTHER REPORTED THAT THE SORE NOW APPEARED TO BE HEALING WITH NEW SKIN AND THERE WAS NO BLEEDING WITH LAST WAFER CHANGE. THE PATIENT CONTINUED TO USE THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10545346 ↗