MEDLINE MSCEX77EPRecalls & reported problems
Medline Industries, Inc. · OPTIFOAM GENTLE EX, SACRUM, 7X7 · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888277652651), received between Feb 11, 2026 and Sep 30, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Patient Device Interaction Problem3
- Loss of or Failure to Bond1
- Material Twisted/Bent1
- Physical Resistance/Sticking1
Patient problems
- Localized Skin Lesion2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond; Material Twisted/Bent
This VMSR report summarizes three malfunction events that occurred during Q3 2024 (July 1, 2024 through September 30, 2024). The account reported increased problems with re-adhesion of the silicone border, poor absorption capability, premature rolling of the adhesive border, and poor tack down associated with Optifoam Gentle EX Silicone-Faced Foam Dressings, catalog number MSCEX77EPH. No patient age, weight, sex, race, or ethnicity information was available. No patient or user injuries were reported. The division will continue to monitor complaints through quarterly trend reporting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945604 ↗MalfunctionSep 17, 2026Patient Device Interaction Problem; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808715 ↗InjuryMar 4, 2026Patient Device Interaction Problem
CUSTOMER INFORMED AND REPORTED THAT HE HAD AN ALLERGIC REACTION TO FOAM DRESSING. CUSTOMER INFORMED HE GOT BLISTERS AND OPEN SORES.
Patient problems: Localized Skin Lesion
MAUDE report 24504964 ↗InjuryFeb 11, 2026Patient Device Interaction Problem
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.