BARD 0112660Recalls & reported problems

Summary

The FDA's MAUDE database contains 237 adverse event reports that list this exact device (DI 00801741016516), received between Apr 12, 2017 and Aug 26, 2026 — classified as 4 deaths, 229 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (209 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 237 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2009 - Patient was diagnosed with incisional hernia and ventral hernia thereby underwent open repair with implant of Bard Flat Mesh (Device 1). Per operative notes, ¿A vertical incision was made directly from the umbilicus up to the superior portion of the hernia that was marked preoperatively. Left and right of umbilicus there was exposing the multiple hernia defects. The hernia defects were dissected free from surrounding tissues and were reduced back into the peritoneal cavity. Once the anterior abdominal wall had been repaired well as the umbilicus hernia defect repaired a piece of Bard Flat Mesh (Device 1) was placed into intra-abdominal wall and secured it with sutures.¿(b)(6) 2013 - Patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of Bard Flat Mesh (Device 2). Per operative notes, ¿An incision was made in the abdominal wall extending from the xiphoid down to the umbilicus. The hernia sac was dissected out. Previously placed Bard Flat Mesh (Device 1) was identified, which was intact. A Bard Flat Mesh (Device 2) was placed into the anterior abdominal wall with old mesh and secured it with sutures.

  Patient problems: Abscess; Post Operative Wound Infection

  MAUDE report 50458138 ↗
• InjuryJul 30, 2026Device Appears to Trigger Rejection

  Per information provided:On (b)(6) 2009 - Patient was diagnosed with two incisional hernias thereby underwent open repair with implant of Bard Flat Mesh (Device 1 and Device 2). Per op notes, ¿The midline fascial defect was approached first. An incision was made on the pervious scar. The hernia sac was identified and isolated from the fascia. A Bard Flat Mesh (Device 1) was placed on the defect and was secured with sutures. To repair the hernia in the kidney transplant scar (RLQ), the previous scar was excised and dissected the subcutaneous tissue down to fascia. The hernia sac was identified and isolated from the fascia. A Bard Flat Mesh (Device 2) was placed on the defect and secured with sutures." On (b)(6) 2009 - Patient was diagnosed with incarcerated incisional hernia and small bowel obstruction thereby underwent repair. Per op notes, "Noted the previously placed Bard Flat Mesh (Device 2) in the RLQ was intact with small bowel protruding through it. Adhesions were dissected free. A synthetic mesh was placed to the abdominal wall defect with tacks. The previously placed mesh (Device 1) was left on top of the defect and was still in place. And another synthetic mesh was placed

  Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion

  MAUDE report 50083002 ↗
• InjuryJun 11, 2026Patient-Device Incompatibility

  AS PER ANSM N° R2616339: DATE OF OCCURRENCE: (B)(6) 2025 DESCRIPTION OF THE INCIDENT: MEDIAN HERNIA REPAIR: SINGLE RETRO-MUSCULAR PREPERITONEAL PROSTHESIS (BARD FLAT MESH) FOR A MEDIAN PERI- AND SUPRA-UMBILICAL HERNIA, 5 CM IN DIAMETER. (B)(6) 2021: TOTAL HYSTERECTOMY, OMENTECTOMY, PELVIC AND LUMBO-AORTIC DRAINAGE VIA LAPAROTOMY. RESULT: MESONEPHRIC-LIKE OVARIAN ADENOCARCINOMA. (B)(6) 2021: CONSULTATION FINDINGS: MESONEPHRIC-LIKE OVARIAN CARCINOMA WITH INVASION OF THE SIGMOID COLON. APPROVAL OF ADJUVANT CHEMOTHERAPY WITH CARBOPLATIN-TAXOL. PATIENT'S CURRENT CONDITION: ABDOMINAL PAIN, FATIGUE, STRESS, EXHAUSTION. ACTIONS TAKEN AT THE HEALTHCARE FACILITY TO MANAGE THE PATIENT: NOT REPORTED (NR).

  Patient problems: Abdominal Pain; Anxiety; Fatigue

  MAUDE report 25473325 ↗
• InjuryMar 4, 2026Migration

  PER INFORMATION PROVIDED: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OP NOTES, ¿PRIOR INCISION WAS RE-OPENED. A LARGE LEFT LOWER QUADRANT HERNIA DEFECT CONTAINING THE OMENTUM WAS IDENTIFIED AND REDUCED. A COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED WITHIN THE FASCIAL DEFECT AND SECURED WITH SUTURES.¿ (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXCISION OF COMPOSIX KUGEL MESH (DEVICE 1). PER OP NOTES, ¿A PALPABLE BULGE WAS NOTED IN THE LEFT LOWER QUADRANT. A LARGE AMOUNT OF MESH BEGINS TO EXTRUDE THROUGH THE HERNIA DEFECT INTO THE ANTERIOR ABDOMINAL WALL. THE MESH WAS NOT FIXED TO THE ABDOMINAL WALL, EXTRUDING THROUGH THE FASCIA AND ERODING THE ABDOMINAL WALL. THE MESH (DEVICE 1) WAS EXCISED, AND THE REMAINING MESH WAS WELL INCORPORATED. THE DEFECT WAS CLOSED PRIMARILY WITH SUTURES.¿ (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX KUGEL MESH (DEVICE 1) AND IMPLANT OF BARD FLAT MESH (DEVICE 2). PER OP NOTES, ¿A VERTICAL MIDLINE INCISION WAS MADE.

  Patient problems: Adhesion(s); Hematoma; Obstruction/Occlusion

  MAUDE report 24504680 ↗
• InjuryFeb 4, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿A MIDLINE INCISION WAS MADE NEAR THE XIPHOID, AND THE HERNIA WAS IDENTIFIED IN THE UPPER PART OF THE ABDOMEN. MULTIPLE DEFECTS WITHIN THE FASCIA WAS NOTED AND THE INCARCERATED OMENTUM WAS FREED UP AND RESECTED. A BARD FLAT MESH (DEVICE 1) WAS PLACED TO THE FASCIA AND TACKED WITH SUTURES.¿ ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿INCISION WAS MADE ON THE LEFT UPPER QUADRANT. ADHESIONS NOTED ALONG THE ABDOMINAL WALL WERE TAKEN DOWN. SEVERAL LOOPS OF SMALL BOWEL TOWARD THE RIGHT SIDE OF ABDOMEN WERE TAKEN DOWN. BOWEL STUCK TO THE ABDOMINAL WALL WAS TAKEN DOWN. THE OLD MESH WAS VISUALIZED FROM PRIOR HERNIA REPAIR. A SYNTHETIC MESH WAS PLACED THROUGH THE LEFT UPPER QUADRANT INCISION AND SECURED WITH SUTURES.¿ ON (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXCISION OF SYNTHETIC MESH AND IMPLANT OF BIOL

  Patient problems: Abscess; Adhesion(s); Hernia; Obstruction/Occlusion; Scar Tissue; Unspecified Infection

  MAUDE report 24256326 ↗
• InjuryNov 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE PERITONEAL CAVITY. HERNIA SAC WAS DISSECTED OUT. A SEPRAMESH IP (DEVICE 1) WAS PLACED INTO THE ABDOMINAL CAVITY AND SECURE IT WITH SUTURES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA, PAIN, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF SEPRAMESH IP (DEVICE 1) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE RIGHT LOWER ABDOMEN. HERNIA SAC WAS DISSECTED OUT. THERE WAS DENSE ADHESION INTO THE ABDOMEN, WHICH WAS REMOVED ENTIRELY. PREVIOUSLY PLACED SEPRAMESH IP (DEVICE 1) WAS CRUMPLED AND THAT WAS REMOVED ENTIRELY. A SYNTHETIC MESH WAS PLACED INTO THE DEFECT AND SUTURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL HERNIA, ADHESION, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 2) AND PHASIX FLAT MESH (DEVICE 3). PER OPERATIVE NOTES, ¿A LOWER ABDOMEN VENTRAL HERNIA SAC WAS IDENTIFIED. HERNIA SAC WAS EXCISED FROM ABDOMEN. LYSIS OF ADHESION WA

  Patient problems: Necrosis; Wound Dehiscence

  MAUDE report 23664440 ↗
• InjuryNov 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2003- PATIENT WAS DIAGNOSED WITH MASSIVE INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1 AND 2). PER OP NOTES, ¿A LARGE PORTION OF HERNIA SAC WAS IDENTIFIED IN THE ABDOMINAL REGION WHICH WAS COMPLETELY EXCISED. A TWO 10 X 14 BARD FLAT MESH (DEVICE 1 AND 2) WAS PLACED IN THE DEFECT REGION AND SUTURED¿. (B)(6) 2004- PATIENT WAS DIAGNOSED WITH LEFT VENTRAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD COMPOSIX KUGEL HERNIA PATCH (DEVICE 3) AND PARTIAL EXPLANT OF BARD MESH (DEVICE 1 AND 2). PER OP NOTES, ¿FACIAL DEFECT IDENTIFIED IN THE LEFT ABDOMINAL REGION AND WAS DISSECTED. SMALL BOWEL FOUND ADHESED TO THE BARD FLAT MESH (DEVICE 1 AND 2) WAS RESECTED. A BARD COMPOSIX KUGEL HERNIA PATCH (DEVICE 3) WAS PLACED IN THE ABDOMINAL REGION AND SUTURED¿. (B)(6) 2006- PATIENT WAS DIAGNOSED WITH MASSIVE VENTRAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX MESH (DEVICE 4). PER OP NOTES, ¿A LARGE EPIGASTRIC HERNIA WAS IDENTIFIED. ADHESIOLYSIS WAS PERFORMED. A SYNTHETIC MESH WAS THEN PLACED IN THE DEFECT AND SUTURED. DUE TO SUTURE BREAK THE SYNTHETIC MESH WAS REMOVED AND A COMPOSIX MESH (DEVIC

  Patient problems: Fibrosis; Hernia; Inflammation

  MAUDE report 23656154 ↗
• InjurySep 16, 2025Migration; Migration

  PER INFORMATION PROVIDED: (B)(6) 2005 ¿ PATIENT WAS DIAGNOSED WITH SYMPTOMATIC VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OPERATIVE NOTES, ¿THE PATIENT WAS FOUND TO HAVE A LARGE VENTRAL HERNIA IN THE LOWER HALF OF THE INCISION. A BARD FLAT MESH (DEVICE 1) WAS PLACED ON TOP OF THE REPAIR AND SECURED USING STAPLES.¿ (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH LARGE VENTRAL HERNIA AND INTRAABDOMINAL ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿MULTIPLE ADHESIONS WERE TAKEN DOWN. THERE WAS A SMALL HERNIA DEFECT ON LEFT SIDE. A SYNTHETIC MESH WAS PLACED INTO ABDOMEN USING PROTACK STAPLES.¿ (B)(6) 2011 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF SYNTHETIC MESH AND IMPLANT OF BARD FLAT MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE PREVIOUS SYNTHETIC MESH WAS DISPLACED AND PULLED MORE TO THE MIDLINE AND ADHERED TO SMALL BOWEL WAS EXCISED ALONG WITH PROTACK STAPLES. A PIECE OF BARD FLAT MESH (DEVICE #2) WAS PLACED ON TOP OF REPAIR USING SUTURES.¿ (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA; SEROMA THERE

  Patient problems: Adhesion(s); Hernia; Seroma

  MAUDE report 23061071 ↗
• InjuryAug 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 1999 - PATIENT WAS DIAGNOSED WITH UMBILICAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OP NOTES, "A BARD FLAT MESH (DEVICE #1) WAS PLACED AND SUTURED." (B)(6) 1999 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL MIDLINE HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF BARD FLAT MESH (DEVICE #1) AND IMPLANT OF BARD FLAT MESH (DEVICE #2). PER OP NOTES, "ADHESIONS WERE LYSED. THE MESH (DEVICE #1) WAS EXCISED, AND A BARD FLAT MESH (DEVICE #2) WAS PLACED AND SUTURED." (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE #3). PER OP NOTES, "A BARD FLAT MESH (DEVICE #3) WAS PLACED AND SUTURED." (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INFECTION, ABDOMINAL WALL ABSCESS THEREBY UNDERWENT PARTIAL EXPLANT OF BARD FLAT MESH (DEVICE #2 & #3). PER OP NOTES, "THE ABSCESS WAS DRAINED, AND THE INFECTED MESH (DEVICE #2 & #3) WAS RESECTED AND REMOVED." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INFECTION, RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT EXPLANT OF BARD FLAT MESH (DEVICE #2 & #3). PER OP NOTES, "LYSIS OF ADHESIONS WAS PERFORM

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22685206 ↗
• InjuryAug 1, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 1999 - PATIENT WAS DIAGNOSED WITH UMBILICAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OP NOTES, "A BARD FLAT MESH (DEVICE #1) WAS PLACED AND SUTURED." (B)(6) 1999 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL MIDLINE HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF BARD FLAT MESH (DEVICE #1) AND IMPLANT OF BARD FLAT MESH (DEVICE #2). PER OP NOTES, "ADHESIONS WERE LYSED. THE MESH (DEVICE #1) WAS EXCISED, AND A BARD FLAT MESH (DEVICE #2) WAS PLACED AND SUTURED." (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE #3). PER OP NOTES, "A BARD FLAT MESH (DEVICE #3) WAS PLACED AND SUTURED." (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INFECTION, ABDOMINAL WALL ABSCESS THEREBY UNDERWENT PARTIAL EXPLANT OF BARD FLAT MESH (DEVICE #2 & #3). PER OP NOTES, "THE ABSCESS WAS DRAINED, AND THE INFECTED MESH (DEVICE #2 & #3) WAS RESECTED AND REMOVED." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INFECTION, RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT EXPLANT OF BARD FLAT MESH (DEVICE #2 & #3). PER OP NOTES, "LYSIS OF ADHESIONS WAS PERFORM

  Patient problems: Abscess; Adhesion(s); Unspecified Infection

  MAUDE report 22685205 ↗
• InjuryJul 30, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT UNDERWENT SURGICAL INTERVENTION FOR METASTATIC ENDOMETRIAL CARCINOMA IN THE LEFT LOWER QUADRANT THEREBY UNDERWENT IMPLANT OF BARD FLAT MESH (DEVICE #1 & #2). (NOTE: NO IMPLANT OP NOTES WERE PROVIDED FOR THIS PROCEDURE.) ON (B)(6) 2012 - PATIENT UNDERWENT SURGICAL INTERVENTION FOR METASTATIC ENDOMETRIAL CARCINOMA IN THE LEFT UPPER QUADRANT THEREBY UNDERWENT IMPLANT OF BARD FLAT MESH (DEVICE #3). PER OP NOTES, "A LARGE ABDOMINAL WALL DEFECT WAS IDENTIFIED, AND A BARD FLAT MESH (DEVICE #3) WAS PLACED AND SUTURED." ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT AND PERSISTENT PAIN IN THE LEFT UPPER QUADRANT AND LEFT SUBCOSTAL REGION THEREBY UNDERWENT EXPLORATION OF LEFT UPPER QUADRANT AND LEFT SUBCOSTAL REGION. ON (B)(6) 2014 - PATIENT UNDERWENT SURGICAL INTERVENTION FOR METASTATIC ENDOMETRIAL CARCINOMA IN THE RIGHT LOWER QUADRANT, ADHESIONS THEREBY UNDERWENT LYSIS OF ADHESIONS AND REPAIR OF ABDOMINAL WALL DEFECT WITH IMPLANT OF BIOLOGICAL MESH. PER OP NOTES, "LYSIS OF ADHESIONS WAS PERFORMED IN THE BOWEL AND UNDERSIDE OF THE PREVIOUSLY PLACED MESH (DEVICE #1, #2 & #3). A BIOLOGICAL MESH WAS PLACED AND SUTURED."

  Patient problems: Adhesion(s); Pain

  MAUDE report 22662999 ↗
• InjuryJun 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE # 1). PER OP NOTES, "A BARD FLAT MESH (DEVICE # 1) WAS PLACED AND SUTURED." ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #2). PER OP NOTES, "A VENTRALEX MESH (DEVICE # 2) WAS PLACED AND SUTURED." ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR. ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF BARD FLAT MESH (DEVICE # 1) AND VENTRALEX MESH (DEVICE #2) AND IMPLANT OF SEPRAMESH IP (DEVICE # 3). PER OP NOTES, "ADHESIONS WERE TAKEN DOWN. THE MESHES (DEVICE # 1 & # 2) WERE REMOVED AND A SEPRAMESH IP (DEVICE # 3) WAS PLACED AND SUTURED." ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE # 4). PER OP NOTES, "A VENTRALIGHT ST USING ECHO PS (DEVICE # 4) WAS PLACED AND TACKED."

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22343716 ↗
• InjuryJun 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH MULTIPLE INCISIONAL HERNIA OF OLD MIDLINE INCISION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A BARD FLAT MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCISIONAL VENTRAL WALL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #2). PER OPERATIVE NOTES, ¿ONE BARD FLAT MESH (DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INFECTED ABDOMINAL WALL MESH POST VENTRAL HERNIA REPAIR, SEROMA, PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXPLORATION OF ABDOMINAL WALL WOUND, DRAINAGE OF SUBFASCIAL SEROMA. PER OPERATIVE NOTES, ¿OLD MESH WAS NOT REMOVED.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #3). PER OPERATIVE NOTES, ¿ONE BARD FLAT MESH (DEVICE #3) WAS PLACED AND SUTURED.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH PERSISTENT PAIN STATUS POST VENTRAL HERNIA REPAIR, SUSPECTED SUTURE GRANULOMA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF SEVERAL SUTURE GRANULOMA.

  Patient problems: Granuloma; Pain

  MAUDE report 22217701 ↗
• InjuryMay 23, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA AND MIDLINE INCISIONAL HERNIA THEREBY UNDERWENT BILATERAL LAPAROSCOPIC INGUINAL REPAIR AND OPEN INCISIONAL HERNIA REPAIR WITH IMPLANT 3DMAX MESH- RIGHT (DEVICE #1) AND 3DMAX MESH - LEFT (DEVICE #2) AND BARD FLAT MESH (DEVICE #3). PER OPERATIVE NOTES, ¿THE RIGHT DIRECT HERNIA WAS IDENTIFIED, DISSECTED AND PLACED WITH 3DMAX MESH (DEVICE #1) AND IN LEFT SIDE THE INDIRECT INGUINAL HERNIA WAS IDENTIFIED AND REPAIRED USING 3DMAX MESH (DEVICE #2). THE MIDLINE INCISIONAL HERNIA SAC WAS IDENTIFIED AND DISSECTED DOWN TO THE LEVEL OF FASCIA AND BARD FLAT MESH (DEVICE #3) WAS PLACED CLOSED WITH STAPLES.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE #4). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND DISSECTED DOWN TO THE LEVEL OF FASCIA AND BARD FLAT MESH (DEVICE #4) WAS PLACED AND SUTURED.¿ (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH UPPER ABDOMINAL PAIN AND UPPER ABDOMINAL ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC ADHESIOLYSIS. PER OPERATIVE NOTES, ¿THE NUMEROUS OMENTAL ADHESIONS TO THE UPPER ABDOMINAL WALL

  Patient problems: Abdominal Pain; Adhesion(s)

  MAUDE report 22076028 ↗
• DeathMar 28, 2025Defective Device; Patient-Device Incompatibility; Material Deformation; Defective Device; Patient-Device Incompatibility; Material Deformation

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD FLAT MESH ON (B)(6) 2001. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD FLAT MESH. ATTORNEY ALLEGES WRONGFUL DEATH OF THE PATIENT AND 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: Bowel Perforation; Insufficient Information; Nerve Damage; Pain; Unspecified Infection

  MAUDE report 21718126 ↗
• InjuryMar 26, 2025Defective Device; Patient Device Interaction Problem; Defective Device; 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: Hernia

  MAUDE report 21696075 ↗
• InjuryFeb 13, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH LARGE LEFT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF BARD FLAT MESH (DEVICE #1) AND IMPLANT OF BARD FLAT MESH (DEVICE #2 & #3). PER OPERATIVE NOTES, ¿HERNIA SAC WAS EXCISED. A MARLEX MESH (DEVICE #2 & #3) WAS PLACED AND ATTACHED TO THE FASCIA USING SUTURES. PROTRUDING PROLENE SUTURES AND MARLEX MESH (DEVICE #1) WERE EXCISED.¿ (THERE WAS NO IMPLANT OPERATIVE NOTES PROVIDED FOR BARD FLAT MESH (DEVICE #1)). (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH LEFT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #4). PER OPERATIVE NOTES, ¿HERNIA SAC WAS EXCISED AND SMALL BOWEL WAS REDUCED BACK INTO THE PERITONEAL CAVITY. A MARLEX MESH (DEVICE #4) WAS PLACED AND ATTACHED TO THE FASCIA USING STAPLES.¿ (THERE WERE NO VISUALIZATION/MENTION OF BARD FLAT MESH (DEVICE #2 & DEVICE #3). (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #5 & DEVICE #6) AND PARTIAL EXPLANT OF BARD FLAT MESH (DEVICE #2, DEVICE #3 & DEVICE #4). PER OPERATIVE NOTES, ¿A LARGE HERNIA DEFECT WAS NOTED TOWARDS THE RIG

  Patient problems: Adhesion(s); Hernia; Necrosis

  MAUDE report 21373204 ↗
• InjuryJan 21, 2025Defective 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) ON (B)(6) 2007. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT 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 21194868 ↗
• MalfunctionJun 27, 2024Off-Label Use; Off-Label Use

  AS REPORTED, THE BARD FLAT MESH WAS AUTOCLAVED PRIOR TO PREPARING A PATIENT FOR HERNIA REPAIR, DURING WHICH THE MESH SIZE WAS REDUCED TO THE POINT WHERE IT CANNOT BE USED NORMALLY. AS REPORTED, A NEW PIECE WAS RE-CUT AND URGENTLY STERILIZED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624188 ↗
• InjuryMar 13, 2024Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  PER MEDICAL RECORDS: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC AND INCARCERATED OMENTUM WERE IDENTIFIED AND REDUCED. A VENTRALEX MESH (DEVICE#1) WAS THEN PLACED IN AN UNDERLAY FASHION WITH SUTURES. SEPRAFILM WAS PLACED UNDERNEATH TO HELP PREVENT WITH ANY ADHESIONS.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INTERNAL HEMORRHOIDS THEREBY UNDERWENT SCREENING COLONOSCOPY. (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE #1) AND IMPLANT OF BARD FLAT MESH (DEVICE #2). PER OPERATIVE NOTES, ¿DISSECTION WAS DIFFICULT SECONDARY TO PRIOR MESH, MULTIPLE ADHESIONS, SIGNIFICANT SCAR TISSUE AND MESH BEING FOLDED OVER ON ITSELF. ONCE THE MESH (DEVICE #1) WAS REMOVED, WERE ABLE TO DISSECT AND CAREFULLY SEPARATED FROM THE ADHERED PIECE OF BOWEL. A PIECE OF BARD FLAT MESH (DEVICE #2) WHICH WAS SECURED IN PLACE WITH SUTURE TO THE RECTUS MUSCLE AND ANTERIOR SHEATH. MESH WAS NOTED TO BE IYING IN FLAT AND ADEQUATE POSITION. AN ADDITIONAL PIECE OF BARD FLAT MESH WAS LAID OVER THE ANTERIOR SHEATH AND O

  Patient problems: Post Operative Wound Infection

  MAUDE report 18892134 ↗
• MalfunctionDec 19, 2023Off-Label Use; Off-Label Use

  AS REPORTED, THE BARD FLAT MESH WAS AUTOCLAVED PRIOR TO PREPARING A PATIENT FOR HERNIA REPAIR AND THE MESH SIZE WAS REDUCED TO THE POINT WHERE IT COULD NOT BE USED. IT WAS ALSO REPORTED THAT A NEW PIECE WAS CUT AND URGENTLY STERILIZED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361523 ↗
• InjuryOct 31, 2023Defective Device; Patient-Device Incompatibility; 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), BARD/DAVOL VENTRALEX ST PATCH AND PHASIX ST ON (B)(6) 2014 AND/OR (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH) AND VENTRALEX ST PATCH. 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; Bacterial Infection; Insufficient Information

  MAUDE report 18038099 ↗
• InjurySep 28, 2023Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX ON (B)(6) 2010 AND BARD MESH (FLAT SHEET) ON (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2022. 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; Necrosis; Pain; Unspecified Infection

  MAUDE report 17832192 ↗
• InjuryJul 19, 2023Defective 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 Mesh (Bard Flat Mesh) on (b)(6) 2022. 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.Addendum Per additional information provided:(b)(6) 2022 - Patient was diagnosed with ventral incisional hernia thereby underwent open repair with implant of Bard Flat Mesh. Per operative notes, ¿An incision was made into the umbilical area through previous scar. An unknown mesh was encountered in this area. The unknown mesh was excised entirely. The hernia sac was dissected out. A Bard Flat Mesh was placed into the anterior abdominal wall and secured it with sutures.¿ (Note: There is no product identifier provided for the mesh explanted during this procedure, Hence the mesh will be considered as unknown)(b)(6) 2022 - Patient was diagnosed with abdominal wall abscess with infected mesh, fibrosis, purulent discharge thereby underwent open repair with exp

  Patient problems: Abscess; Fibrosis; Insufficient Information; Purulent Discharge; Unspecified Infection

  MAUDE report 17348436 ↗
• InjuryJul 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  FDA REPORTED TO RTI BIOLOGICS THAT A PATIENT WHO WAS TREATED WITH TWO RTI ALLOMAX GRAFTS AND A BARD/DAVOL MESH (CONSUMER REPORTED EVENTCC 181431). AS REPORTED, ¿MESH WAS USED TO REPAIR HERNIA IN 2009¿. ¿THE COMPLAINANT STATES SHE HAS PAIN AND BLEEDING¿. ¿SHE SAYS THE MESH IS BREAKING THROUGH HER SKIN¿. INFORMATION REPORTED TO RTI WAS FORWARDED TO BD. CONTACT WITH THE AGENCY CONFIRMED THAT CONSUMER CONTACT INFORMATION CANNOT BE PROVIDED. AS SUCH THIS IS ALL OF THE KNOWN INFORMATION. ADDENDUM PER ADDITIONAL INFORMATION RECEIVED THROUGH MEDWATCH REPORT #MW5154314: "A PATIENT CALLED TO REPORT THE ADVERSE EVENTS SHE HAS BEEN EXPERIENCING FROM MESH IMPLANT AND ALLOMAX GRAFT SHE HAD IN 2009. SHE STATED A COUPLE OF WEEKS AGO, SHE WAS RUSHED TO THE EMERGENCY ROOM FROM VOMITING AND ABDOMINAL PAIN. BLOOD WORK SHOWED THAT SHE WAS ABOUT TO LOSE HER KIDNEY FUNCTION. SHE SAID THE DOCTOR HAD TO RUSH HER TO THE OPERATING ROOM TO REMOVE THE MESH. SHE SAID THE SURGEON HAD TO CUT HER UP ALL THE WAY TO HER VAGINA. SHE SAID THE WOUND STILL HAS NOT HEALED. SHE SAID SHE IS STILL IN PAIN FROM THE PROCEDURE. SHE SAID HER BOWEL HURTS SO BAD. SHE SAID SHE HAD 2 BOWEL PROLAPSES AFTER THE MESH IMPLANT AND ALLOM

  Patient problems: Abdominal Pain; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Pain; Prolapse

  MAUDE report 17282823 ↗