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COMPOSIX 0134114Recalls & reported problems

Davol Inc. · Bard Composix L/P Mesh, 10.2" x 14.2" (26.1 cm x 36.2 cm), Rectangle · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741031250), received between Jun 2, 2021 and Jun 2, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Defective Device1
  • Patient Device Interaction Problem1

Patient problems

  • Abscess1
  • Adhesion(s)1
  • Hernia1
  • Insufficient Information1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryJun 2, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX L/P (X2) ON (B)(6) 2007 AND VENTRALEX HERNIA PATCH ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO COMPOSIX L/P (DEVICE #1 & #2). PER OP NOTES, ¿TWO COMPOSIX L/P MESH (DEVICE #1 & #2) WERE PLACED WITHIN THE ABDOMEN AND TACKED TO THE LEFT ASPECT OF THE HERNIA USING SUTURES.¿ (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF DULEX MESH (DEVICE #3). PER OP NOTES, ¿OMENTAL ADHESIONS WERE TAKEN DOWN. A DULEX MESH (DEVICE #3) WAS PLACED IN THE ABDOMEN AND TACKED TO THE OVERLYING PERITONEUM USING SUTURES.¿ (NOTE: THERE IS NO MENTION/VISUALIZATION OF PREVIOUSLY PLACED COMPOSIX L/P (DEVICE #1 & #2

    Patient problems: Abscess; Adhesion(s); Hernia; Insufficient Information; Unspecified Infection

    MAUDE report 11920964 ↗

Other Mesh, surgical, polymeric devices

All Mesh, surgical, polymeric devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.