MEDLINE MSCEX99EPRecalls & reported problems
Medline Industries, Inc. · OPTIFOAM GENTLE EX, SACRUM, 9X9 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888277652668), received between Sep 21, 2026 and Sep 25, 2026 — classified as 3 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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 Problem4
- Loss of or Failure to Bond3
- Adhesive Too Strong1
Patient problems
- Peeling3
- Pressure Sore/Ulcer3
- Skin Inflammation/ Irritation2
- Pain1
- Skin Tears1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Loss of or Failure to Bond
Patient problems: Pressure Sore/Ulcer
MAUDE report 50903487 ↗InjurySep 25, 2026Loss of or Failure to Bond
According to the facility, "the ICU brought up the increase in HAPIs on the units and the use of the Medline Foams." Per the customer contact, "the nurses reported the foams rolling, not as user friendly when lifted to inspect the tissue, etc." It was reported, "the new product was brought into the unit in April and the facility acquired 7 sacral HAPIs in 6 months" and "this resulted in wounds to patients and longer hospital stays." Unspecified medical intervention was required.
Patient problems: Pressure Sore/Ulcer
MAUDE report 50898217 ↗InjurySep 25, 2026Loss of or Failure to Bond
According to the facility, "the ICU brought up the increase in HAPIs on the units and the use of the Medline Foams." Per the customer contact, "the nurses reported the foams rolling, not as user friendly when lifted to inspect the tissue, etc." It was reported, "the new product was brought into the unit in April and the facility acquired 7 sacral HAPIs in 6 months" and "this resulted in wounds to patients and longer hospital stays." Unspecified medical intervention was required.
Patient problems: Pressure Sore/Ulcer
MAUDE report 50897572 ↗MalfunctionSep 25, 2026Patient Device Interaction Problem
It was reported that "adhesive not sticking well on Sacral EX. Some also vocalized that the adhesive is sticking too well in some cases and causing skin injury."
Patient problems: Pain; Peeling
MAUDE report 50897545 ↗MalfunctionSep 22, 2026Patient Device Interaction Problem
It was reported that "the 9x9 sacral and heel dressing are too sticky and causing patients skin to peel off when removing."
Patient problems: Peeling; Skin Inflammation/ Irritation
MAUDE report 50855293 ↗MalfunctionSep 22, 2026Patient Device Interaction Problem; Adhesive Too Strong
It was reported that the 9x9 sacral and heel dressing are too sticky and causing patients skin to peel off when removing.
Patient problems: Peeling; Skin Inflammation/ Irritation
MAUDE report 50853704 ↗MalfunctionSep 21, 2026Patient Device Interaction Problem
It was reported that they were "having some issues with the Optifoam Gentle products tearing patient's skin and causing patients to have to extend their stays."
Patient problems: Skin Tears
MAUDE report 50841258 ↗
Other Dressing, wound, occlusive devices
- DUODERM 187957Convatec, Purchasing Department · Dressing, Wound, Occlusive4,342 reports
- DUODERM 187955Convatec, Purchasing Department · Dressing, Wound, Occlusive1 recall2,348 reports
- DUODERM 187660Convatec, Purchasing Department · Dressing, Wound, Occlusive207 reports
- DUODERM 187961Convatec, Purchasing Department · Dressing, Wound, Occlusive153 reports
- SAM Chest Seal CS203-ENSAM Medical Products · Dressing, Wound, Occlusive1 recall0 reports
- DUODERM 187662Convatec, Purchasing Department · Dressing, Wound, Occlusive43 reports
- ALLEVYN LIFE L 15.4X15.4 CTN10 66801069Smith & Nephew Medical Limited · Dressing, Wound, Occlusive28 reports
- ALLEVYN LIFE SACRUM (LARGE) PACK OF 10 66801307Smith & Nephew Medical Limited · Dressing, Wound, Occlusive28 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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