Skip to content

COMPOSIX 0144790Recalls & reported problems

Davol Inc. · Composix L/P Mesh with PS Echo PS Positioning System, 7.2" x 9.2" (18.4 cm x 23.5 cm), Ellipse · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741031366), received between Jan 23, 2020 and Dec 25, 2020 — classified as 2 injuries.

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

Most reported problems

Device problems

  • Defective Device2
  • Insufficient Device Problem Information2
  • Device Appears to Trigger Rejection1
  • Patient-Device Incompatibility1

Patient problems

  • Injury2
  • Pain2
  • Adhesion(s)1
  • Disability1
  • Hernia1
  • Obstruction/Occlusion1
  • Scar Tissue1

Recent adverse event reports

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

  • InjuryDec 25, 2020Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information; Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX L/P ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR ¿PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

    Patient problems: Adhesion(s); Disability; Hernia; Injury; Obstruction/Occlusion; Pain; Scar Tissue

    MAUDE report 11073474 ↗
  • InjuryJan 23, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX L/P, VENTRALEX HERNIA PATCH AND VENTRIO PATCH. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST COMPOSIX L/P AND VENTRALEX HERNIA PATCH WHICH WERE IMPLANTED ON (B)(6) 2018. 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.

    Patient problems: Injury; Pain

    MAUDE report 9621251 ↗

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.