ONFLEX 0115611Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741095405), received between Aug 6, 2018 and Aug 6, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT UNDERWENT THE REPAIR OF A BILATERAL INGUINAL HERNIA (DIRECT). THE SURGEON REPORTS THE PROCEDURE WAS ¿PERFECTLY ADEQUATE¿ AND ¿FELT THE MESH WAS PLACED WELL.¿ AS REPORTED THE NEXT DAY THE PATIENT UNDERWENT A REVISION PROCEDURE FOR THE LEFT SIDED REPAIR. IT IS REPORTED THAT THE "MEDIAL INFERIOR QUADRANT WAS ¿FOLDED¿ ALLOWING SAC UNDER MESH TO DIRECT DEFECT. THIS WAS CORRECTED, AND MESH LEFT IN SITU."

  Patient problems: Hernia

  MAUDE report 7754425 ↗
• InjuryAug 6, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT UNDERWENT LEFT INGUINAL HERNIA (DIRECT) REPAIR AND WAS IMPLANTED WITH A MODIFIED ONFLEX MESH. AS REPORTED "FAILURE OF REPAIR WAS EVIDENT THE NEXT MORNING." ON (B)(6) 2018 THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE MEDIAL UPPER AND LOWER CORNERS WERE FOUND TO BE ¿FOLDED¿ ALLOWING PREPERITONEAL FAT TO ENTER DIRECT DEFECT. AN ADDITIONAL FATTY LUMP WAS ALSO REMOVED DURING THE REVISION PROCEDURE AND THE MESH WAS SUTURED TO HELP SECURE REPAIR. DEVICE REMAINS IN SITU.

  Patient problems: Hernia

  MAUDE report 7754412 ↗