DULEXRecalls & reported problems across all models
Davol Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls
- 0
We found 10 models of DULEX by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Jun 9, 2017 and Feb 26, 2026 — classified as 23 injuries, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported DULEX problems
Device problems
- Defective Device17
- Patient-Device Incompatibility12
- Patient Device Interaction Problem9
- Insufficient Device Problem Information7
- Material Deformation3
- Migration2
- Inadequate Service1
- Material Disintegration1
Patient problems
- Adhesion(s)14
- Hernia13
- Pain8
- Injury7
- Unspecified Infection5
- Disability4
- Abscess3
- Insufficient Information3
DULEX models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DULEX 0110151Mesh, surgical, polymeric6 reports
- DULEX 0115191Mesh, surgical, polymeric3 reports
- DULEX 0118241Mesh, surgical, polymeric3 reports
- DULEX 0120301Mesh, surgical, polymeric3 reports
- DULEX 0110152Mesh, surgical, polymeric2 reports
- DULEX 0126341Mesh, surgical, polymeric2 reports
- DULEX 0175101Mesh, surgical, polymeric2 reports
- DULEX 0108121Mesh, surgical, polymeric1 report
- DULEX 0115192Mesh, surgical, polymeric1 report
- DULEX 0126342Mesh, surgical, polymeric1 report
Recent DULEX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2026Patient-Device Incompatibility
PER INFORMATION PROVIDED: ON (B)(6) 2003 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OPERATIVE NOTES, ¿OVER THE VENTRAL HERNIA IN THE MIDLINE, THE SAC WAS REDUCED AND COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED AND SECURED IN PLACE WITH SUTURES CIRCUMFERENTIALLY ON BOTH SUPERIOR AND INFERIOR EDGES.¿ ON (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH INFECTED ABDOMINAL WALL MESH (DEVICE 1) THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿IN THE MIDLINE, THE INFECTED OLD MESH (DEVICE 1) WAS DISSECTED FROM SURROUNDING TISSUES AND THEN EXCISED. AN OLD UNKNOWN MESH WAS EXPOSED, AND THIS WAS ALSO EXCISED. THE FASCIA WAS CLEARED AND SYNTHETIC MESH WAS PLACED OVER THE FASCIAL DEFECT AND DEFECT WAS REPAIRED CIRCUMFERENTIALLY WITH SUTURES.¿ (NOTE: THE MESH REMOVED DURING THIS PROCEDURE IS UNKNOWN). ON (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, IN THE LOWER ABDOMEN, THE FISTULA EXTENDED WITH RECURRENCE OF THE PREVIOUSLY NOTED HERNIA. THE HERNIA DEFECT WAS REDUCED, AND A
Patient problems: Abscess
MAUDE report 24451774 ↗InjuryFeb 18, 2026Patient-Device Incompatibility
PER INFORMATION PROVIDED: ON (B)(6) 2010- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF BARD DULEX MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED IN THE ABDOMINAL REGION AND WAS DISSECTED. A BARD DULEX MESH (DEVICE 1) WAS PLACED AND SUTURED¿. ON (B)(6) 2012- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 2). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED IN THE RIGHT LOWER QUADRANT WHICH WAS ABOVE THE PREVIOUSLY PLACED MESH (DEVICE 1). A VENTRALIGHT ST MESH (DEVICE 2) WAS CUT AND PLACED IN THE DEFECT REGION AND SUTURED¿. ON (B)(6) 2013- PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF BARD DULEX MESH (DEVICE 1), VENTRALIGHT ST MESH (DEVICE 2), IMPLANT OF VENTRALIGHT ST MESH (DEVICE 3). PER OP NOTES, ¿THE RECURRENT HERNIA SAC WAS IDENTIFIED IN THE ABDOMINAL REGION AND WAS REDUCED. A VENTRALIGHT ST MESH (DEVICE 3) WAS PLACED AND SUTURED¿.
Patient problems: Hernia
MAUDE report 24380814 ↗InjuryDec 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
PER INFORMATION PROVIDED: (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OP NOTES, ¿ADHESIONS WERE LYSED. THERE WERE MULTIPLE HERNIA DEFECTS THAT WERE NOTED AND REDUCED. THE SMALL BOWEL DIVERTICULUM WAS NOTED AND RESECTED. THE HERNIA DEFECTS WITH OMENTUM WERE REDUCED. A COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED AND SUTURED.¿ (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA AND ABDOMINAL MASS THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX KUGEL MESH (DEVICE 1) AND IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿THE SCAR WAS EXCISED. PURULENT MATERIAL WAS NOTED AND DRAINED. NECROTIC FAT WAS EXCISED. THE MESH WAS NOTED AND EXCISED ENTIRELY. THE DEFECT WAS IDENTIFIED AND REPAIRED WITH SYNTHETIC MESH.¿ (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH NON-HEALING WOUND THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF SCAR, DEBRIDEMENT OF FASCIA AND HERNIA REPAIRED WITH SUTURES. (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF DULEX MESH (DEVICE 2). PER OP NOTES, ¿LARGE SCAR WAS
Patient problems: Hernia; Necrosis; Unspecified Infection
MAUDE report 23727465 ↗InjuryJul 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
PER INFORMATION PROVIDED: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT LOWER QUADRANT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF DULEX MESH (DEVICE #1). PER OP NOTES, ¿A DULEX MESH (DEVICE #1) WAS ORIENTED IN AN OBLIQUE FASHION AND SUTURED CIRCUMFERENTIALLY.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH LEFT LOWER QUADRANT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX L/P MESH (DEVICE #2). PER OP NOTES, ¿THE PREVIOUSLY PLACED MESH (DEVICE #1) WAS REPERITONEALIZED AND DISSECTED THE ADHESIONS. A COMPOSIX L/P MESH (DEVICE #2) WAS PLACED INTO THE DEFECT AND TACKED USING SORBAFIX FIXATION DEVICE.¿
Patient problems: Adhesion(s); Hernia
MAUDE report 22552992 ↗InjuryMay 14, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem
PER 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) DURING THIS REPAIR). (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #4). PER OP NOTES, ¿A SMALL DEFECT WAS NOTED IN THE LEFT LOWER QUADRANT WHERE TWO PREVIOUS PLACED MESHES (DEVICE # 1 & # 2) COME TOGETHER. A VENTRALEX MESH (DEVICE #4) WAS PLACED IN THE ABDOMEN AND TACKED OVER TO OVERLIE THE DEFECT.¿ (NOTE: THERE IS NO MENTION/VISUALIZATION OF PREVIOUSLY PLACED DULEX M
Patient problems: Abscess; Adhesion(s); Hernia; Unspecified Infection
MAUDE report 22021480 ↗InjuryApr 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
AS REPORTED, THE PATIENT WAS IMPLANTED WITH DULEX MESH FOR A HERNINA REPAIR. THE PATIENT PRESENTED WITH A BULGE FROM HERNIA AND PAIN. AS REPORTED, "HE NEVER HEALED FROM THE HERNIA PROCEDURE AND WAS SUPPOSED TO HAVE ANOTHER ONE TO REMOVE THE MESH, BUT PROVIDER LEFT IN AND SNIPPED THE CORNERS AND HAD TO HAVE A DRAIN TUBE AS WELL AND BECAME SEPTIC. WE WAITED ANOTHER 6-8 WEEKS AND HAD TO HAVE ANOTHER PROVIDER REMOVE THE MESH BY ANOTHER PROCEDURE ON (B)(6) 2016.
Patient problems: Pain; Sepsis
MAUDE report 21918544 ↗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 ↗InjuryMar 26, 2025Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem
PER INFORMATION PROVIDED: (B)(6) 2001 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS DISSECTED, AND A COMPOSIX MESH (DEVICE #1) WAS PLACED AND SUTURED." (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF DULEX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿LYSIS OF ADHESIONS WAS PERFORMED. A DUAL MESH (DEVICE #2) WAS PLACED AND TACKED." (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF COMPOSIX MESH (DEVICE #1) AND IMPLANT OF BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿THE MESH (DEVICE #1) WAS FOUND DISRUPTED FROM THE ANTERIOR ABDOMINAL WALL WAS EXCISED COMPLETELY AND REMOVED. THE MESH (DEVICE #2) ON THE RIGHT SIDE WAS FOUND IN GOOD POSITION. A BIOLOGICAL MESH WAS PLACED AND SUTURED." (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF DULEX MESH (DEVICE #2) AND BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS REDUCED. LYSIS OF ADHESIONS WAS PE
Patient problems: Adhesion(s); Hernia
MAUDE report 21696076 ↗InjuryMar 5, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem
PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH COMPLEX RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD DULEX MESH . PER OPERATIVE NOTES, "THE HERNIA SAC WAS DISSECTED FREE FROM THE FEMORAL CANAL INTO THE GROIN AREA, THE PREVIOUSLY PLACED UNKNOWN MESH WAS DISLODGED FROM THE HERNIA SAC. THE PREVIOUS UNKNOWN MESH WAS EXCISED FROM IT'S INFLAMMATORY MASS IN THE INGUINAL CANAL. THE HERNIA DEFECT WAS CLOSED AND REDUCED. A BARD DULEX MESH (DEVICE #1) WAS PLACED MEDIAL TO THE PUBIC TUBERCLE ALONG THE INGUINAL LIGAMENT AND SUTURED." (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH BILATERAL SYMPTOMATIC RECURRENT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED TRANSABDOMINAL LAPAROSCOPIC PREPERITONEAL BILATERAL INGUINAL HERNIA REPAIR WITH IMPLANT OF 3DMAX LIGHT MESHES (DEVICE #2 & #3). PER OPERATIVE NOTES, "THE BILATERAL INGUINAL HERNIA WAS NOTED, THE PREPERITONEAL MESH (DEVICE #1) WAS SEEN. THE MESH WAS ADHERENT TO THE PERITONEUM. THE LARGE HERNIA SAC WAS REDUCED ON THE LEFT SIDE. THE SAME PROCESS WAS DONE ON RIGHT SIDE. A 3DMAX LIGHT MESH (DEVICE #2) SUTURED TO COOPER LIGAMENT IN INTERRUPTED FASHION ON LEFT SIDE, SIMILAR REPAIR WAS DONE O
Patient problems: Adhesion(s); Hernia; Pain; Scar Tissue
MAUDE report 21523608 ↗InjuryFeb 21, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem
PER INFORMATION PROVIDED: (B)(6)2010 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF DULEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿IN THE LEFT LOWER QUADRANT, SOME DENSE ADHESIONS TO THE SAC WERE DIVIDED. THERE WAS AN ADDITIONAL SUPERIOR ASPECT HERNIA JUST TO THE RIGHT OF MIDLINE WAS IDENTIFIED, ADHESIONS WERE DIVIDED. A CUTANEOUS BRIDGE WHICH HAD AN OLD PIECE OF MESH WAS DIVIDED, AND A DULEX MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6)2012 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT FLANK HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE PARTIAL REMOVAL OF DULEX MESH (DEVICE #1) AND IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿AFTER EXTENSIVE LYSIS OF ADHESIONS, THE HERNIA SAC WAS DISSECTED. THE PREVIOUS MESH (DEVICE #1) WAS RESECTED AND REMOVED. A VENTRALIGHT ST MESH (DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6)2015 - PATIENT WAS DIAGNOSED WITH MULTI-RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF DULEX MESH (DEVICE #1) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS FOUND HERNIATED INTO THE SIGMOID COLON. THE ADHESIONS WERE LYSED, AND HERNIA
Patient problems: Adhesion(s); Hernia; Scar Tissue
MAUDE report 21431423 ↗InjuryDec 13, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem
ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL DULEX MESH ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST DULEX MESH. 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: Abdominal Pain; Adhesion(s); Insufficient Information; Nerve Damage; Unspecified Infection
MAUDE report 15968420 ↗InjuryOct 14, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem
ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2006. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH). 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: Insufficient Information; Pain
MAUDE report 15605943 ↗InjuryApr 19, 2022Material Disintegration; Patient-Device Incompatibility; Material Disintegration; Patient-Device Incompatibility
AS REPORTED, DURING AN INCISIONAL HERNIA REPAIR PROCEDURE ON (B)(6) 2004, THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL DULEX MESH. IT WAS REPORTED, ABOUT 6 YEARS LATER IN 2010 THE PATIENT UNDERWENT ADDITIONAL SURGERY TO REMOVE ABDOMINAL WALL SCARRING. AS REPORTED ON (B)(6) 2021, THE PATIENT EXPERIENCED EXCRUCIATING PAIN AND PRESENTED TO THE HOSPITAL EMERGENCY ROOM. AS REPORTED, A CT SCAN WAS PERFORMED AND IDENTIFIED 2 BOWEL BLOCKAGES AND A TWISTED AREA OF BOWEL. IT WAS REPORTED THE SURGEON WOULD NOT PERFORM ANY SURGICAL PROCEDURE AND ADMINISTERED A ¿DYE¿ TO TEMPORARILY RESOLVE THE BLOCKAGES AND TWISTED BOWEL. AS REPORTED, THE PATIENT HAS CONTINUED WITH SIGNIFICANT ABDOMINAL BLOATING/SWELLING, AND THE PATIENT¿S ABDOMEN IS HARD TO THE TOUCH AND PAINFUL. AS REPORTED THE PATIENT HAS TRIED MULTIPLE REMEDIES SUCH AS GAS-X, MINT TEA, MULTIPLE DOCTOR VISITS WITH NO RELIEF. CONTACT REPORTS THE PATIENT EXPERIENCED HEALTH ISSUES RELATED TO THE ¿MESH DISINTEGRATING AND ALLOWS INTESTINES TO GROW INTO THE MESH.¿ PER THE CONTACT, THE MESH HAS ¿WELDED ITSELF AGAINST THE BOWELS AND SKIN CAUSING TROUBLE EATING AND BLOATING.¿ IT IS REPORTED THAT THE PATIENT IS WAITING FOR SURGERY IN THE NEAR FUTURE.
Patient problems: Abdominal Pain; Adhesion(s); Obstruction/Occlusion
MAUDE report 14141672 ↗InjurySep 27, 2021Defective Device; Material Deformation; Patient Device Interaction Problem; Migration; Defective Device; Material Deformation; Patient Device Interaction Problem; Migration
ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH). 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: Abscess; Hernia; Insufficient Information; Unspecified Infection
MAUDE report 12531418 ↗InjuryDec 4, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information
ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL DULEX MESH ON OR ABOUT (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE DULEX MESH. 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
MAUDE report 10949417 ↗
Other Davol Inc. products
All Davol Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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