Medline DYNJP6102Recalls & reported problems

Medline Industries, Inc. · DRAPE,C-SECTION,FEN,POUCH,WIRE · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10080196908639), received between Jun 28, 2024 and Jun 28, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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

Insufficient Device Problem Information1

Patient problems

Hypersensitivity/Allergic reaction1

Recent adverse event reports

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

InjuryJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE CUSTOMER, "I HAD A PATIENT RECENTLY WHO HAD A FAIRLY SIGNIFICANT REACTION TO THE C- SECTION DRAPE ADHESIVE (LIKE THE RED/RASH AREA WAS THE EXACT SHAPE OF IT).
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19634133 ↗

Device details

UDI-DI	`10080196908639`
Brand	Medline
Model	DYNJP6102
Company	Medline Industries, Inc.
Product code	PUI · Drape, surgical, exempt
Class	Class 2
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 22, 2021

Device type (GMDN): Patient surgical drape, single-use

A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

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All Drape, surgical, exempt 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 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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