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Medline Industries, Inc. DYNJ82842ARecalls & reported problems

Medline Industries, Inc. · PLASTIC MAJOR PACK · Class 1

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 10195327244736), received between Mar 21, 2023 and Mar 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

Most reported problems

Device problems

  • Contamination /Decontamination Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMar 21, 2023Contamination /Decontamination Problem

    MID 30¿S FEMALE WITH HISTORY OF BILATERAL MACROMASTIA. PROCEDURE: BILATERAL REDUCTION MAMMOPLASTY. WHEN THE PLASTIC MAJOR PACK WAS OPENED FOR USE, THERE WAS A HARD, BROWN DEBRIS IN THE PACKAGE. NOT USED ON THE PATIENT. NO KNOWN HARM. MANUFACTURER RESPONSE FOR PLASTIC SURGERY AND ACCESSORIES KIT, MEDLINE INDUSTRIES, INC. (PER SITE REPORTER) WILL LOOK INTO IT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16582028 ↗

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Sources and updates

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