Medline Industries, Inc. PHS397101008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889942037810), received between Nov 1, 2017 and Nov 1, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other 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

Recent adverse event reports

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

• MalfunctionNov 1, 2017Device Contamination with Chemical or Other Material

  OPERATING ROOM (OR) OPENED FOR LAPAROSCOPIC PREPERITONEAL BILATERAL INGUINAL HERNIA REPAIRS WITH A MINOR ABDOMINAL PACK. THE SURGICAL TEAM OPENED FOR THE PROCEDURE, WHEN THE SA NOTED A LONG, BLACK HAIR WITHIN THE LAPAROTOMY SPONGE. A PICTURE WAS TAKEN, THE ROOM WAS TORN DOWN, AND THE PACK WAS GIVEN TO THE CHARGE LEAD NURSE. QUALITY AND SAFETY, AS WELL AS THE MANUFACTURER REPRESENTATIVE, WERE MADE AWARE. A NEW PACK WAS SET UP AND THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO HARM TO THE PATIENT. PER SITE REPORTER: THE MANUFACTURER REPRESENTATIVE WAS NOTIFIED AND PICKED UP THE CONTAMINATED PACK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6992771 ↗