MEDLINE MSC97410Recalls & reported problems

Medline Industries, Inc. · OPTIFOAM GENTLE SA AG,POST-OP,4X10 · Class U

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888277415386), received between Sep 22, 2026 and Sep 22, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Dislodged or Dislocated1
Patient Device Interaction Problem1

Patient problems

Erythema1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 22, 2026Device Dislodged or Dislocated; Patient Device Interaction Problem
It was reported that "Complaints of dressing not adhering well on patients even when skin is dry on dressing application" and "Redness/skin reaction Observation of redness under dressing on some patients."
Patient problems: Erythema
MAUDE report 50855284 ↗

Device details

UDI-DI	`10888277415386`
Brand	MEDLINE
Model	MSC97410
Company	Medline Industries, Inc.
Product code	FRO · Dressing, wound, drug
Class	Class U
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Jun 4, 2026

Device type (GMDN): Exudate-absorbent dressing, non-gel, antimicrobial

A wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.

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All Dressing, wound, drug devices →

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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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