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Medline Industries, Inc. DYNJ35686BRecalls & reported problems

Medline Industries, Inc. · BREAST AUG 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 10889942488315), received between Jul 3, 2019 and Jul 3, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Sparking” (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

  • Sparking1

Patient problems

  • Superficial (First Degree) Burn1

Recent adverse event reports

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

  • MalfunctionJul 3, 2019Sparking

    IT WAS REPORTED THAT DURING A PLASTICS PROCEDURE, THE CAUTERY DEVICE SPARKED AND THE PATIENT EXPERIENCED A 1ST DEGREE BURN.

    Patient problems: Superficial (First Degree) Burn

    MAUDE report 8758437 ↗

Other Plastic surgery and accessories kit devices

All Plastic surgery and accessories kit devices →

Sources and updates

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