COMPOSIX 0144113Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741031328), received between Feb 19, 2019 and Feb 19, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 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.

• InjuryFeb 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT IN 2012 THE PATIENT WAS DIAGNOSED WITH MULTIPLE VENTRAL HERNIAS S/P A HYSTERECTOMY AND REMOVAL OF A TUMOR. THE PATIENT UNDERWENT AN OPEN REPAIR WITH COMPONENT SEPARATION AND PLACEMENT OF AN ¿UNKNOWN MESH.¿ AS REPORTED, ABOUT 4 YEARS LATER THE PATIENT WAS DIAGNOSED WITH EXTENSIVE ABDOMINAL ADHESIONS, MULTIPLE HERNIA DEFECTS, DIASTASIS, CHOLECYSTIS. ON (B)(6) 2016 THE PATIENT UNDERWENT REMOVAL OF HER GALLBLADDER AND LAPAROSCOPIC REPAIR OF THE MULTIPLE HERNIAS. AS REPORTED A BARD COMPOSIX L/P MESH W/ ECHO WAS USED FOR THE REPAIR WHICH WAS SECURED WITH A NON BARD/DAVOL FIXATION DEVICE. AS REPORTED THE PATIENT IS HAVING SEVERE ABDOMINAL PAIN, SWELLING AND A HARDENED AREA ON HER ABDOMEN. REPORTEDLY, THE PATIENT HAS MADE MULTIPLE VISITS TO THE HOSPITAL ER WITH COMPLAINTS OF PAIN AND TREATED ACUTELY. THE PATIENT HAD SEEN HER PRIMARY CARE DOCTOR WHO INFORMED HER SHE WOULD MOST LIKELY NEED TO HAVE THE MESH REMOVED. AS REPORTED THE PATIENT HAS NOT FOLLOWED UP WITH HER SURGEON BECAUSE "SHE IS AFRAID SHE WILL NEED TO HAVE SURGERY".

  Patient problems: Abdominal Pain; Swelling; Swelling/ Edema; Weight Changes

  MAUDE report 8351722 ↗