BARD 0112720Recalls & reported problems

Summary

The FDA's MAUDE database contains 191 adverse event reports that list this exact device (DI 00801741016561), received between Aug 6, 2014 and Aug 12, 2026 — classified as 189 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (156 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

Recent adverse event reports

The 25 most recent of 191 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)-2009 - Patient was diagnosed with small bowel obstruction and incarcerated ventral hernia thereby underwent open repair with the removal of Composix mesh (Device 1) and implant of two Bard Flat Mesh (Device 2 and 3). Per op notes, "Adhesiolysis was performed. The prior Composix mesh (Device 1) was removed which was located more on the lateral aspect of the incision from the hernia recurrence. Two separate pieces of Bard Flat Mesh (Device 2 and 3) were placed in an onlay fashion over the fascia using sutures." (b)(6)-2010 - Patient was diagnosed with incarcerated ventral hernia with wound abscess thereby underwent repair with removal of infected mesh (Device 2 and 3). Per op notes, "The ventral hernia was encountered, the hernia sac was separated from the fascia and the infected mesh. The mesh (Device 2 and 3) were excised from the abdominal wall. The infected mesh was separated from the extensive scar tissue attached to it, it was excised from the abdominal wall and removed. A biologic mesh was then placed."

  Patient problems: Abscess; Hernia; Scar Tissue; Unspecified Infection

  MAUDE report 50224486 ↗
• MalfunctionApr 23, 2026Device Contamination with Chemical or Other Material

  AS REPORTED DURING A PROCEDURE, IMPURITIES (WHITE FLOCCULENT) WERE FOUND IN THE PACKAGE OF A FLAT MESH. THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS PROPERLY SEALED BEFORE OPENING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967616 ↗
• InjuryApr 22, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2009: PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF KUGEL HERNIA PATCH (DEVICE 1). (NOTES: NO OP NOTES WERE PROVIDED). (B)(6) 2014: PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS AND LEFT FLANK ABDOMINAL WALL HERNIA THEREBY UNDERWENT OPEN REPAIR FOR RIGHT INGUINAL HERNIA WITH THE IMPLANT OF PERFIX PLUG (DEVICE 2) AND LEFT INGUINAL HERNIA WITH PERFIX PLUG (DEVICE 3), BARD FLAT MESH (DEVICE 4) AND LEFT FLANK OR ABDOMINAL WALL HERNIA WITH VENTRALEX MESH (DEVICE 5). PER OP NOTES, "AN INCISION TO THE RIGHT INGUINAL LIGAMENT, A PERFIX PLUG (DEVICE 2) WAS PLACED USING SUTURES. ATTENTION TO THE LEFT SIDE, A PERFIX PLUG (DEVICE 3) AND A BARD FLAT MESH (DEVICE 4) WERE PLACED. THEN AN INCISION TO THE LEFT FLANK OR ABDOMINAL WALL HERNIA, A VENTRALEX MESH (DEVICE 5) WAS PLACED USING SUTURES." (B)(6) 2014: PATIENT WAS DIAGNOSED WITH LEFT GROIN HEMATOMA, THEREBY UNDERWENT LEFT GROIN WOUND EXPLORATION AND EVACUATION OF HEMATOMA. PER OP NOTES, "FOUND A SMALL SIZED SEROMA IN THE LEFT INGUINAL REGION THAT WAS ASPIRATED. PATIENT DEVELOPED SWELLING AND PAIN INVOLVING THE LEFT GROIN REGION. A HEMATOMA WAS IDENTIF

  Patient problems: Hematoma; Pain; Seroma

  MAUDE report 24951134 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCISIONAL ABDOMINAL WALL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD SOFT MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN INFRAUMBILICAL MIDLINE INCISION WAS MADE THROUGH SUBCUTANEOUS TISSUE. THE HERNIA SAC WAS EXCISED ENTIRELY. A BARD SOFT MESH (DEVICE 1) WAS PLACED INTO THE DEFECT AND CLOSED WITH SUTURES.¿ ON (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH COMPLEX LEFT ABDOMINAL WALL AND RECURRENT INCISIONAL ABDOMINAL WALL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL PATCH (DEVICE 2) AND BARD FLAT MESH (DEVICE 3). PER OPERATIVE NOTES, ¿AN INCISION WAS CAREFULLY DISSECTED DOWN THROUGH THE SUBCUTANEOUS TISSUE INTO THE MIDLINE. THE RECURRENT INCISIONAL ABDOMINAL WALL HERNIA SAC WAS DISSECTED OUT. THERE WERE SOME DENSE ADHESIONS WHICH WERE DISSECTED OUT. A COMPOSIX KUGEL PATCH (DEVICE 2) WAS PLACED INTO THE MIDLINE OF ABDOMEN. AN INCISION WAS MADE INTO THE LEFT ANTERIOR ABDOMINAL WALL. THE HERNIA SAC WAS DISSECTED OUT. A BARD FLAT MESH (DEVICE 3) WAS PLACED INTO THE LEFT ABDOMINAL WALL AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH LEFT ABDOMINAL WOUND IN

  Patient problems: Hernia; Post Operative Wound Infection; Seroma

  MAUDE report 24703316 ↗
• InjuryFeb 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013- PATIENT WAS DIAGNOSED WITH EPIGASTRIC HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿THE EPIGASTRIC HERNIA WAS IDENTIFIED AND DISSECTED. A BARD FLAT MESH (DEVICE 1) WAS PLACED AND SUTURED TO THE PERITONEAL LAYER¿. (B)(6) 2015- PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿DEFECT WAS NOTED ON THE RIGHT UPPER QUADRANT. A SYNTHETIC MESH WAS PLACED ON THE DEFECT AND TACKED¿. (B)(6) 2015- PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF BARD FLAT MESH (DEVICE 1) AND IMPLANT OF BARD FLAT MESH (DEVICE 2). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED IN THE ABDOMINAL REGION AND WAS DISSECTED. THE MESH WAS FOUND INCORPORATED INTO THE HERNIA SAC. A SAC ALONG WITH THE ENTIRETY OF THE FIRST PIECE OF MESH BARD FLAT MESH (DEVICE 1) FROM ORIGINAL ANTERIOR REPAIR WAS EXCISED. THE OTHER MESH (SYNTHETIC MESH) FROM THE LAPAROSCOPIC VENTRAL REPAIR WAS ALSO EXCISED. A BARD FLAT MESH (DEVICE 2) WAS PLACED WITHIN THE RETRORECTUS SPACE AND SUTURED¿. (B)(6) 2019- PATIEN

  Patient problems: Hernia

  MAUDE report 24377148 ↗
• InjuryJan 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿PREVIOUS INFRAUMBILICAL VERTICAL SCAR WAS REOPENED. A LARGE HERNIA WITH SMALL BOWEL HERNIA WAS IDENTIFIED AND REDUCED. A BARD FLAT MESH (DEVICE 1) WAS PLACED OVER THE COMPLETED CLOSURE OF FASCIA AND TACKED WITH SUTURES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 2). PER OP NOTES, ¿INCISION WAS MADE ABOVE THE UMBILICUS AND REOPENED THE PRIOR INCISION. THE OVERLAY MESH (DEVICE 1) WAS INTACT. A VENTRALIGHT ST MESH (DEVICE 2) WAS PLACED AS AN UNDERLAY AND SECURED WITH SUTURES.¿ (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH EXCISION OF VENTRALIGHT ST (DEVICE 2) AND IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿PREVIOUS SUBLAY MESH (DEVICE 2) WAS IDENTIFIED WITH LARGE AMOUNT OF ADHESIONS AND SCAR TISSUE WHICH WAS DISSECTED FREE. A VENTRALIGHT ST (DEVICE 2) WAS EXCISED. THE ONLAY MESH (DEVICE 1) WAS LEFT IN PLACE. A SYNTHETIC MESH WAS PLACED INTO THE P

  Patient problems: Adhesion(s); Hernia; Scar Tissue

  MAUDE report 24207869 ↗
• InjuryJan 9, 2026Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OPERATIVE NOTES, ¿THE PALPABLE HERNIA DEFECT FROM PREVIOUS UMBILICAL HERNIA WAS NOTED. THE CHRONIC HERNIA WITH SCARRING FIBROSIS AND ADHESIONS TO SAC WAS REDUCED. THE SACS WERE EXCISED AND BARD FLAT MESH (DEVICE 1) WAS PLACED AND SECURED WITH SUTURES CIRCUMFERENTIALLY.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 2). PER OPERATIVE NOTES, ¿ IN THE MID ABDOMEN, A LARGE RECURRENT HERNIA WAS DISSECTED FREE FROM SURROUNDING TISSUES AND COMPOSIX KUGEL MESH (DEVICE 2) WAS PLACED IN THE ABDOMINAL WALL DEFECT AND SEWN IN PLACE. THE FASCIA WAS CLOSED AND SECURED WITH SUTURES.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH SEROMA OF ABDOMINAL WALL AND ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH ASPIRATION OF ABDOMINAL WALL SEROMA. PER OPERATIVE NOTES, ¿THE SEROMA FLUID APPEARED CLEAR AND ASPIRATED. THE WOUND WAS IRRIGATED AND FASCIA WAS CLOSED.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURREN

  Patient problems: Adhesion(s); Hernia; Seroma

  MAUDE report 24018542 ↗
• InjuryJan 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH HERNIA, THEREBY UNDERWENT REPAIR WITH IMPLANT OF BARD FLAT MESHES (DEVICE 1 AND 2). (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE) (B)(6) 2019- PATIENT WAS DIAGNOSED WITH PAIN, THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿THE WOUND WAS NOTED NEAR THE MESH AND IT WAS PAINFUL. YELLOW DRAINAGE OBSERVED IN THAT AREA NEAR THE MESH. THE WOUND WAS CLEANSED AND NO LEAK FOUND¿.

  Patient problems: Fluid Discharge; Pain

  MAUDE report 23942771 ↗
• InjuryJan 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX KUGEL (DEVICE 1). PER OP NOTES, ¿OMENTAL ADHESIONS WERE LYSED. TWO DEFECTS WERE NOTED IN THE UPPER ABDOMEN LATERAL TO PRIOR MESH. BOTH DEFECTS WERE JOINED. A COMPOSIX KUGEL (DEVICE 1) WAS PLACED INTO THE ABDOMEN COVERING BOTH DEFECTS AND SECURED USING TACKS.¿ (NOTE: THE PRIOR MESH VISUALIZED DURING THIS PROCEDURE WAS UNKNOWN) (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX KUGEL (DEVICE 1) AND IMPLANT OF BARD FLAT MESH (DEVICE 2). PER OP NOTES, ¿A SMALL HERNIA SAC WAS NOTED CONTAINED PERITONEAL FAT WERE DISSECTED DOWN AT THE LEVEL OF FASCIA AND EXCISED. ADHESIONS WERE LYSED. THE OLD KUGEL TYPE MESH (DEVICE 1) WAS UNDERNEATH THE HERNIA AND HAD COME LOOSE, SLIPPED FROM THE TISSUES CREATING HERNIA. THE MESH (DEVICE 1) WAS EXCISED. THE DEFECT WAS NOTED AND REDUCED. A BARD FLAT MESH (DEVICE 2) WAS PLACED AND SECURED WITH SUTURES.¿ (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VISILEX MESH (DEVI

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23941383 ↗
• InjuryDec 4, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OP NOTES, ¿THE DEFECT WAS TUCKED BACK INTRAABDOMINALLY. A MEDIUM DUAL SIDED VENTRALEX ST MESH (DEVICE 1) WAS PLACED IN UNDERLAY FASHION AND SUTURED.¿ (B)(6) 2014 ¿ PATIENT HAD CHRONIC PURULENT DRAINAGE AND WAS DIAGNOSED WITH INFECTED MESH, RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1). PER OP NOTES, ¿THERE WAS CLEAR PURULENT DRAINAGE FROM THE UMBILICUS AND FROM THE FASCIA ITSELF. THE INFECTED MESH (DEVICE 1) WAS REMOVED IN ITS ENTIRETY. THERE WAS EVIDENCE OF A RECURRENT UMBILICAL HERNIA AS WELL WHERE A PIECE OF PREPERITONEAL FAT WAS SLIPPING UP OVER THE MESH WAS REMOVED AND CLOSED USING SUTURES.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 2). PER OP NOTES, ¿HERNIA SAC WAS DISSECTED FREE FROM THE SUBCUTANEOUS TISSUE AND TRUNCATED AT THE FASCIAL EDGE. ADHESIONS BETWEEN BOWEL OMENTUM AND ANTERIOR ABDOMINAL WALL WAS CLEARED UP. A BARD FLAT MESH (DEVICE 2) WAS PLA

  Patient problems: Hernia

  MAUDE report 23716525 ↗
• InjuryAug 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT RIGHT HERNIA REPAIR SURGERY WITH THE IMPLANT OF BARD FLAT MESH ON (B)(6) 2010. IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT SUFFERED THE DEVELOPMENT OF CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE AND FURTHER REPARATIVE SURGERIES. AND POLYPROPYLENE SUTURE WAS USED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2018 THE PATIENT WAS IMPLANTED WITH BARD SOFT MESH AND SUBSEQUENT TO THE LATTER SURGERY, THE PLAINTIFF HAS CONTINUED TO SUFFER FROM CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE WHICH RESULTED IN THE PATIENT REQUIRING VARIOUS ADDITIONAL SURGERIES. IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Inflammation; Obstruction/Occlusion

  MAUDE report 22858259 ↗
• InjuryAug 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF THE BARD FLAT MESH (DEVICE #1) AND VENTRALEX ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED. BARD FLAT MESH (DEVICE #1) AND VENTRALEX ST MESH (DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH VENTRAL ABDOMINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE #3). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED OUT. BARD FLAT MESH (DEVICE #3) WAS PLACED AND SECURED WITH SUTURE.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INFECTED ABDOMINAL WALL WOUND THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF OLD BARD FLAT MESH (DEVICE #1), VENTRALEX ST MESH (DEVICE #2) AND BARD FLAT MESH (DEVICE #3). PER OPERATIVE NOTES, ¿ALL THE INFECTED TISSUE AND MESH WAS EXCISED. THE WOUND WAS IRRIGATED. OLD BARD FLAT MESH (DEVICE #1), VENTRALEX ST MESH (DEVICE #2) AND BARD FLAT MESH (DEVICE #3) WERE REMOVED. A WOUND VAC WAS APPLIED.¿

  Patient problems: Unspecified Infection

  MAUDE report 22684247 ↗
• InjuryJul 24, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE #1). PER OP NOTES, "IDENTIFIED THE UNKNOWN MARLEX MESH. A COMPOSIX KUGEL MESH (DEVICE #1) WAS PLACED INTO THE ABDOMINAL WALL USING PROLENE SUTURES." (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH SEROMA THEREBY UNDERWENT REPAIR WITH DEBRIDEMENT OF SEROMA SINUS, DRAINAGE OF SEROMA AND DEBRIDEMENT WITH PRIMARY CLOSURE. (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS WITH INFECTED MESH THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE #1) AND LYSIS OF ADHESIONS. PER OP NOTES, ¿THE COMPOSIX GRAFT APPEARED AS A HARD MASS. DENSE ADHESIONS WERE IDENTIFIED AND THE PRIOR COMPOSIX GRAFT (DEVICE #1) WAS REMOVED. UNKNOWN MARLEX MESH WAS ALSO EXCISED.¿ (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL HERNIA WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #2). PER OP NOTES, ¿A BARD FLAT MESH (DEVICE #2) WAS PLACED INTO THE ABDOMINAL WALL USING PROLENE SUTURES.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT SMALL BOWEL OBS

  Patient problems: Hernia; Obstruction/Occlusion

  MAUDE report 22592870 ↗
• InjuryJul 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL MARLEX MESH (CAT#0112720, LOT # HUFZ1081) ON (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE MARLEX MESH. 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: Insufficient Information; Pain

  MAUDE report 22412014 ↗
• InjuryJun 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO BARD FLAT MESH (DEVICE #1 ¿ LEFT, DEVICE #2 ¿ RIGHT). PER OP NOTES, ¿ON LEFT, BARD FLAT MESH (DEVICE #1) WAS PLACED INTO DEFECT AND SECURED USING TACKS. ON RIGHT, BARD FLAT MESH (DEVICE #2) WAS POSITIONED AGAINST COVERAGE OF THE DIRECT AND INDIRECT AREAS OF DEFECT AND SECURED USING TACKS.¿ (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH CLOSED LOOP OBSTRUCTION WITH PERFORATED SMALL BOWEL THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE #1, #2). PER NOTES, ¿THERE WAS A LARGE AMOUNT OF FREE FLUID WITHIN THE PERITONEUM ALONG WITH SUCCUS. DENSE ADHESIONS OF THE SMALL BOWEL TO THE PREVIOUSLY PLACED MESH (DEVICE #1, #2) IN THE LEFT LOWER QUADRANT WERE TAKEN DOWN. THERE WAS ONE AREA OF PERFORATION IN THE SMALL BOWEL IN THE PELVIC REGION. SOME AREAS OF SMALL BOWEL WAS INCORPORATED TO THE MESH. THERE WAS SMALL BOWEL ADHERENT TO THE FASCIA MESH (DEVICE #1, #2) POSTERIORLY AND ANTERIORLY WERE TAKEN DOWN. THE PATIENT WAS GETTING SEPTIC AND FOR FURTHER RESUSCITATION TAKEN TO THE ICU.¿ (B)(6) 2014 ¿ PATIENT UNDERWENT SMALL BOWEL RESECTI

  Patient problems: Bowel Perforation; Peritonitis; Sepsis

  MAUDE report 22334629 ↗
• InjuryDec 6, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #1). (NO OPERATIVE NOTES WERE PROVIDED). (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE ANTERIOR WALL WAS CLEARED OF ADHESIONS. THE HERNIA SAC WAS EXCISED. THEN A VENTRALEX MESH (DEVICE #2) WAS PLACED FLAT AND UP AGAINST THE ABDOMINAL WALL USING SUTURES AND STAPLES.¿ (NOTE: THERE WAS NO VISUALIZATION/MENTION OF SEPRAMESH IP (DEVICE #1)). (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA AND ADHESIONS THEREBY UNDERWENT REPAIR WITH REMOVAL OF SEPRAMESH IP (DEVICE #1) AND VENTRALEX MESH (DEVICE #2) AND IMPLANT OF BARD FLAT MESH (DEVICE #3). (NO OPERATIVE NOTES WERE PROVIDED). (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC VENTRAL HERNIA WITH INCARCERATION AND BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF POLYPROPYLENE MESH. PER OPERATIVE NOTES, ¿HERNIA DEFECT IDENTIFIED AT THE UMBILICUS AND LOOP OF BOWEL REMAINING INCARCERATED. BOWEL LOOP WAS DISSECTED FREE FROM PERITONEUM. SEROSAL T

  Patient problems: Hernia; Obstruction/Occlusion

  MAUDE report 20863207 ↗
• InjuryJul 17, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN BARD MESH (BARD FLAT MESH) ON (B)(6) 2012. 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

  MAUDE report 19759279 ↗
• InjuryJul 17, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) (REFERENCE #(B)(4), LOT #HUUA1118) AND BARD/DAVOL PERFIX PLUG ON (B)(6) 2010 AND/OR (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH 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.

  Patient problems: Insufficient Information

  MAUDE report 19758928 ↗
• InjuryJul 17, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 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

  MAUDE report 19758779 ↗
• InjuryMay 8, 2024Defective 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) 2021. 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 REVISION SURGERY ON (B)(6) 2023. 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); Hernia; Insufficient Information; Pain

  MAUDE report 19266297 ↗
• InjuryApr 26, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT WITH HISTORY OF BREAST CANCER, UNDERWENT BREAST RECONSTRUCTION PROCEDURE WHICH GRAFTING FROM HER ABDOMINAL WALL WAS INVOLVED. IN 2007 PATIENT UNDERWENT AN ABDOMINAL WALL RECONSTRUCTION PROCEDURE USING A FLAT MESH FOR SUPPORT. IT WAS REPORTED THAT ABOUT 2 YEARS AGO, PATIENT STARTED TO NOTICE A HARDENED AREA ALONG THE INCISION LINE AND WAS TOLD IT WAS A POSSIBLE HEMATOMA AND THE AREA NEVER RESOLVED. AS REPORTED, IN (B)(6) 2023, THE SURGEON PERFORMED AN EXPLORATORY PROCEDURE AND NOTED A SMALL POCKET OF BLOOD. PATIENT REPORTED OF HAVING THREE MORE BLOOD FILLED AREAS ALONG HER ABDOMINAL WALL THAT HAVE ERUPTED. IT WAS REPORTED THAT SURGEON WOULD LIKE TO PERFORM A REACTIVITY TEST WITH A SAMPLE OF THE MESH PRIOR TO POSSIBLY REMOVING THE ENTIRE PIECE OF MESH FROM THE PATIENT.

  Patient problems: Hematoma; Hypersensitivity/Allergic reaction

  MAUDE report 19189019 ↗
• InjuryApr 24, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL MARLEX (BARD FLAT MESH) PHASIX MESH ON (B)(6) 2015 AND/OR ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE 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.

  Patient problems: Insufficient Information; Pain

  MAUDE report 19171211 ↗
• InjuryMar 12, 2024Defective 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 MARLEX (BARD FLAT MESH) ON 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST MARLEX (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 18886034 ↗
• InjuryAug 11, 2023Defective 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 IMPLANTED OF BARD MESH (BARD FLAT MESH) AND BARD SOFT MESH ON (B)(6) 2020. AS REPORTED THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH 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.

  Patient problems: Insufficient Information; Pain

  MAUDE report 17507752 ↗
• InjuryApr 26, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT BILATERAL INGUINAL HERNIA REPAIR WITH THE IMPLANT OF FLAT MESH (RIGHT AND LEFT) ON (B)(6) 2019. AS REPORTED, ABOUT 6 MONTHS POST OP, THE PATIENT EXPERIENCED ERECTILE DYSFUNCTION AND CONSULTED WITH A UROLOGIST WHO REPORTED IT MAY BE DUE TO HIS ENLARGED PROSTATE. AS REPORTED ABOUT 3 YEARS POST IMPLANT, THE PATIENT DEVELOPED A HARDENED RIDGE LIKE AREA IN THE RIGHT GROIN AREA WITH DISCOMFORT/TENDERNESS WHEN PALPATED. IT WAS REPORTED THAT DURING FOLLOW UP VISIT ON (B)(6) 2023, SURGEON INFORMED THE PATIENT THAT THERE WAS NOTHING WRONG WITH THE AREA OF IMPLANT, NO FURTHER INTERVENTION WAS REQUIRED AND TO FOLLOW-UP WITH THE UROLOGIST REGARDING ERECTILE DYSFUNCTION. IT WAS REPORTED THAT THE PATIENT HAS A UROLOGIST APPOINTMENT IN (B)(6) 2023. CONTACT REPORTS THE PATIENT IS NOT HAVING ANY ISSUES WITH THE LEFT SIDED REPAIR.

  Patient problems: Discomfort; Weight Changes

  MAUDE report 16814037 ↗