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Medline Industries, Inc. DYNJ0396069FRecalls & reported problems

Medline Industries, Inc. · TR-SEPTO-RHINOPLASTY PK-LF · 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 10889942065714), received between Mar 14, 2018 and Mar 14, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination With Biological Material” (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

  • Device Contamination With Biological Material1

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.

  • MalfunctionMar 14, 2018Device Contamination With Biological Material

    AFTER PROCEDURE STARTED, A HAIR WAS FOUND IN THE PACK ON THE OUTSIDE OF THE BASIN. THE SURGICAL TEAM WAS MADE AWARE. THIS DID NOT REACH THE PATIENT, HOWEVER, IT WAS NOT SAVED SINCE THE PROCEDURE WAS ALREADY PROGRESSING, AND STAFF NEEDED TO WORK QUICKLY TO REPLACE SUPPLIES. PER SITE REPORTER: THE FIELD REPRESENTATIVE WAS NOTIFIED AND HE WILL OPEN A COMPLAINT WITH MEDLINE'S QUALITY TEAM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7337320 ↗

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Sources and updates

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