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Medline Industries, Inc. DYNDE1045Recalls & reported problems

Medline Industries, Inc. · TRAY, PELVIC EXAM · Class 2

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 10884389479704), received between Oct 25, 2019 and Oct 25, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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

  • Defective Device1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionOct 25, 2019Defective Device

    DOCTOR USED DISPOSABLE PELVIC KIT TO DO VAGINAL EXAM. HAS TO OPEN 3 KITS BECAUSE THE SPECULUM WAS DEFECTIVE - NO LIGHTS. FDA SAFETY REPORT ID# (B)(4).

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9244632 ↗

Other Obstetrical kit devices

All Obstetrical kit devices →

Sources and updates

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