DULEX 0115192Recalls & reported problems
Davol Inc. · Bard Dulex Mesh · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00801741011856), received between Apr 22, 2025 and Apr 22, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Defective Device1
- Patient Device Interaction Problem1
Patient problems
- Adhesion(s)1
- Hernia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem
PER INFORMATION PROVIDED BY PATIENT¿S ATTORNEY AND REVIEW OF PATIENT MEDICAL RECORDS ON (B)(6) 2007: PATIENT WAS DIAGNOSED WITH VENTRAL AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL (DEVICE #1). PER OPERATIVE NOTES, ¿A VENTRAL HERNIA SAC WAS REDUCED AND PUSHED BACK. THE UMBILICAL SAC ALSO REDUCED. BOTH DEFECTS WERE THEN COVERED WITH AN COMPOSIX KUGEL (DEVICE #1) AND TACKED." ON (B)(6) 2008: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF COMPOSIX KUGEL (DEVICE #1) AND IMPLANT OF COMPOSIX KUGEL (DEVICE #2). PER OPERATIVE NOTES, ¿THE HERNIA SAC NOTED TO THE LEFT OF MIDLINE WAS EXCISED. THE PREVIOUSLY PLACED MESH (DEVICE #1) DISPLACED LATERALLY TO THE RIGHT WAS EXCISED AND REMOVED COMPLETELY. A COMPOSIX KUGEL (DEVICE #2) WAS PLACED AND TACKED." ON (B)(6) 2011: PATIENT WAS DIAGNOSED WITH BOWEL OBSTRUCTION SECONDARY TO WADDED UP MESH (DEVICE #2) THEREBY UNDERWENT PARTIAL EXPLANT OF COMPOSIX KUGEL (DEVICE #2). PER OPERATIVE NOTES, ¿THE MESH (DEVICE #2) HAD BECOME FOLDED OVER UPON ITSELF AND THERE WERE DENSE ADHESIONS OF SMALL BOWEL AT FOCAL POINT OF OBSTRUCTION. ADHESIONS WERE TAKEN D
Patient problems: Adhesion(s); Hernia
MAUDE report 21879150 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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