ACTIVELIFE 022767Recalls & reported problems
Convatec, Purchasing Department · Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 12" Trans, 1 1/2" (38 Mm.) · Class 1
Quick summary
This is a Convatec Activelife one-piece drainable ostomy pouch with a Stomahesive skin barrier. The 60 reports all describe the pre-cut starter holes being cut off center, which kept the pouch from fitting as intended; no harm to patients was reported. There were no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 60
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00768455101573), received between Nov 13, 2018 and Nov 13, 2018 — classified as 60 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (60 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
Device problems
- Malposition of Device60
Patient problems
- No Consequences Or Impact To Patient60
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065669 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065646 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065569 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065567 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065558 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065557 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065517 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065514 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065513 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065512 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065511 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065510 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065439 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065383 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065381 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065321 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065320 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065318 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065316 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065227 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8064716 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8064714 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8064713 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8064707 ↗MalfunctionNov 13, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8064648 ↗
Other Bag, drainage, with adhesive, ostomy devices
- ESTEEM 423657Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM 423643Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM 423653Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM+ 416740Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy55 reports
- ACTIVELIFE 022765Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy53 reports
- ESTEEM 423646Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall1 report
- ESTEEM 423665Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall1 report
- ESTEEM 423647Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.