APLICARE APLS1106Recalls & reported problems

Medline Industries, Inc. · SWABSTCK, BENZOIN TINCTURE, 1/PK, STRL · Class 1

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 4
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00618407611066), received between Jan 3, 2024 and Jan 5, 2024 — classified as 4 injuries.

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

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

Most reported problems

Device problems

Patient Device Interaction Problem4

Patient problems

Skin Inflammation/ Irritation4
Wound Dehiscence4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

InjuryJan 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
WITHIN THREE DAYS OF USE THE PATIENT DEVELOPED A "VIOLENT DERMATITIS".
Patient problems: Skin Inflammation/ Irritation; Wound Dehiscence
MAUDE report 18453972 ↗
InjuryJan 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
WITHIN THREE DAYS OF USE THE PATIENT DEVELOPED A "VIOLENT DERMATITIS.
Patient problems: Skin Inflammation/ Irritation; Wound Dehiscence
MAUDE report 18453405 ↗
InjuryJan 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
WITHIN THREE DAYS OF USE THE PATIENT DEVELOPED A "VIOLENT DERMATITIS".
Patient problems: Skin Inflammation/ Irritation; Wound Dehiscence
MAUDE report 18453281 ↗
InjuryJan 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
WITHIN THREE DAYS OF USE THE PATIENT DEVELOPED A "VIOLENT DERMATITIS".
Patient problems: Skin Inflammation/ Irritation; Wound Dehiscence
MAUDE report 18435742 ↗

Device details

UDI-DI	`00618407611066`
Brand	APLICARE
Model	APLS1106
Company	Medline Industries, Inc.
Product code	NEC · Bandage, liquid, skin protectant
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 9, 2022

Device type (GMDN): Synthetic-polymer liquid barrier dressing, sterile

A sterile liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. After application, this device cannot be reused.

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All Bandage, liquid, skin protectant devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.