Medical Action Industries 402Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10809160000106), received between Dec 7, 2016 and May 30, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Falling” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2017Defective Component; Defective Component

  LAP SPONGE RING DETACHED FROM SPONGE AND WAS DISCOVERED OR SPONGE COUNT AT WHICH TIME IT FELL ONTO THE FLOOR AND WAS RETRIEVED BY OR STAFF. THE SPONGE THEREFORE WAS NOT USED FOR PROCEDURE. THE COMPLAINT LAP SPONGE WAS MEDICAL ACTION INDUSTRIES BRANDED; HOWEVER, THE SPONGES WERE MANUFACTURED BY (B)(4) PROVINCE, JIANERKANG MEDICAL DRESSING CO., LTD OF (B)(4). MW 5066601 WAS RECEIVED FROM FDA FOR THIS OCCURRENCE AS WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 6597786 ↗
• MalfunctionDec 7, 2016Component Missing

  PRIOR TO THE PATIENT'S SURGICAL PROCEDURE, THE INITIAL LAP SPONGE COUNT WAS PERFORMED AND EACH LAP SPONGE HAD A RING ATTACHED TO IT. AT THE CONCLUSION OF THE PROCEDURE, DURING THE FINAL COUNT AND PRIOR TO CLOSURE, ONE LAP PAD WAS FOUND TO BE MISSING ITS RING. THE PATIENT'S ABDOMEN WAS INSPECTED AND THE RING WAS LOCATED AND REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6157709 ↗
• MalfunctionDec 7, 2016Component Falling; Noise, Audible

  DURING THE COUNT OF LAP SPONGES, A NOISE WAS HEARD AND UPON INVESTIGATION, IT WAS FOUND THE RING FROM ONE OF THE LAP SPONGES HAD FALLEN ON THE FLOOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6157674 ↗