MEDLINE MSCEX44EPRecalls & reported problems
Medline Industries, Inc. · OPTIFOAM GENTLE EX, BORDERED, 4X4 · Class 1
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888277652637), received between Jul 7, 2026 and Sep 28, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond3
- Adhesive Too Strong1
- Difficult to Remove1
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Erythema1
- Local Reaction1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Loss of or Failure to Bond
It was reported that "THESE 2 BX ARE NOT STAYING ON WELL. THEY ARE PEELING OFF RIGHT AWAY AND WON'T STICK. SHE BELIEVES THE BOX HAS A DEFECT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916051 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820555 ↗MalfunctionSep 9, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700687 ↗MalfunctionSep 8, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674605 ↗MalfunctionAug 26, 2026Adhesive Too Strong
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50457667 ↗InjuryJul 7, 2026Patient Device Interaction Problem
IT WAS REPORTED, "GENERAL SURGEON HAD 3 PATIENTS COME BACK TO HER OFFICE WITH A REACTION TO THE OPTIFOAM DRESSING THAT HAVE HAD NO PRIOR ALLERGIES/REACTION TO ADHESIVE" AND "PATIENTS HAVE AN AREA OF REDNESS/REACTION OF WHERE THE DRESSING WAS PLACED."
Patient problems: Erythema; Local Reaction
MAUDE report 25735536 ↗
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- DUODERM 187662Convatec, Purchasing Department · Dressing, Wound, Occlusive43 reports
- ALLEVYN LIFE L 15.4X15.4 CTN10 66801069Smith & Nephew Medical Limited · Dressing, Wound, Occlusive28 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.