BARD 0112640Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 00801741016493), received between Jan 14, 2015 and Sep 30, 2026 — classified as 105 injuries.

The most frequently reported specific device problem is “Defective Device” (98 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2014 - Patient was diagnosed with incarcerated umbilical hernia and incisional hernia at port site thereby underwent laparoscopic repair with implant of Bard Flat Mesh (Device 1 and 2). Per op notes, ¿Incision was made just lateral to the port site hernia in the left mid quadrant. Some adhesions were lysed. Lap-band was excised. The port site hernia was noted and reduced. A Bard Flat Mesh (Device 1) was placed and sutured. An infraumbilical incision was made. The umbilical defect was identified in the supraumbilical area with incarcerated omental fat was reduced. Reductant omentum resected. Hernia contents were reduced. A Bard Flat Mesh (Device 2) was placed and sutured.¿ (b)(6) 2017 - Patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with implant of Ventrio ST (Device 3). Per op notes, ¿A vertical laparotomy incision was made just below the level of xiphoid process to just beneath the umbilicus. Multiple hernia sacs were identified. The largest sac was mobilized down. The remaining hernia sac were opened and excised. The incarcerated omentum was reduced. Extensive lysis of adhesions was performed. M

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50945175 ↗
• InjuryMay 27, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1) AND BARD FLAT MESH (DEVICE 2). PER OP NOTES, "A VERY LARGE LIPOMA OF THE CORD WAS IDENTIFIED IN THE LEFT AND DISSECTED FREE AND CONTINUED UP TO THE INTERNAL RING. A PERFIX PLUG (DEVICE 1) WAS PLACED AND SECURED WITH SUTURE. A SMALLER LIPOMA WAS IDENTIFIED IN THE RIGHT SIDE AND SEPARATED FROM THE CORD STRUCTURES AND DISSECTED TO THE INTERNAL RING. A BARD FLAT MESH (DEVICE 2) WAS PLACED AND SECURED WITH SUTURE." ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH BILATERAL RECURRENT HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 3 AND 4). PER OP NOTES, "AN INFRAUMBILICAL INCISION WAS MADE. A SMALL UMBILICAL FASCIAL DEFECT WAS NOTED. A RECURRENT DIRECT LEFT INGUINAL HERNIA WITH A VISIBLE MESH (DEVICE 1) WAS NOTED. A RECURRENT INDIRECT INGUINAL HERNIA WAS IDENTIFIED AT THE RIGHT INGUINAL REGION. A DENSE ADHERENCE OF THE SPERMATIC CORD AND VAS DEFERENS TO THE MESH (DEVICE 2) IN THE RIGHT INGUINAL REGION WAS NOTED. A 3DMAX MESH (DEVICE 3) WAS PLACED IN THE RIGHT AND 3DMAX MESH (DEVICE 4) WAS PLACED I

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 25299805 ↗
• InjuryMay 13, 2026Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2002 ¿ PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL HERNIA CONTAINING INCARCERATED OMENTUM, A SECOND EPIGASTRIC ABDOMINAL WALL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC AND HERNIA CONTENTS WERE ENCOUNTERED IN MIDLINE AND ADDITIONAL DEFECT WAS FOUND INFERIOR TO PREVIOUS HERNIA WAS CONNECTED. A BARD COMPOSIX MESH (DEVICE 1) WAS CUT TO FIT THE DEFECT AND SUTURED TO INNER SURFACE OF FASCIAL MARGIN. THE HERNIA IN EPIGASTRIUM WAS NOTED AND CLOSED USING SUTURES.¿ ON (B)(6) 2006 ¿ PATIENT UNDERWENT IMPLANT OF BARD FLAT MESH (DEVICE 2) AND BARD COMPOSIX MESH (DEVICE 3). PER PATHOLOGY REPORT, ¿THE HERNIA SAC WAS DISSECTED FROM EPIGASTRIC AND LOWER ABDOMINAL AREA.¿ (NOTE: THERE IS NO OP NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS) ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE PARTIAL REMOVAL OF COMPOSIX MESH (DEVICE 1, 3). PER OP NOTES, ¿THE MESH (DEVICE 1) IN THE MIDLINE WHICH WAS ENCOUNTERED. THE MESH WAS DETACHED FROM THE FASCIA. THE MESH HAD SIGNIFICANT NUMBER OF ADHESIONS OF BOTH BOWEL AND OMENTUM ON

  Patient problems: Adhesion(s); Hernia

  MAUDE report 25163530 ↗
• InjuryFeb 26, 2026Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2011 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL FEMORAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO BARD FLAT MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿IN THE RIGHT FEMORAL REGION, A DENSE SCAR TISSUE AND HERNIA WAS NOTED. THERE WAS A DENSE ADHERENCE OF THE UNKNOWN MESH TO THE EXTERNAL OBLIQUE FASCIA AS WELL AS SPERMATIC CORD. THE BARD FLAT MESH (DEVICE 1) WAS PLACED JOINING THE TRANSVERSE ARCH ABOVE AND JOINING THE UNKNOWN MESH INFERIORLY TO COOPER¿S LIGAMENT WITH SUTURES. THE WIDE MOUTH OF HERNIA SAC ON THE BASIS OF THE RHEUMATOID ARTHRITIS WITHIN THE PELVIS WAS NOTED AND ANOTHER BARD FLAT MESH (DEVICE 2) WAS PLACED INTO THE DEFECT MEDIAL TO THE FEMORAL VEIN AND SECURED WITH SUTURES. THE FASCIA WAS CLOSED AND SECURED WITH SUTURES. (NOTE: THE MESH NOTED DURING THIS PROCEDURE IS UNKNOWN) ON (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR WITH SYNTHETIC MESHES. PER OPERATIVE NOTES, ¿ A LARGE DIRECT INDIRECT HERNIAS BILATERALLY WERE NOTED. IN THE RIGHT SIDE, FLAPS WERE CREATED LATERAL TO LARGE HERNIA DEFECT AND HERNIA WAS REDUCE

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24456627 ↗
• InjuryJan 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF DULEX MESH (DEVICE 1). PER OP NOTES, "A DULEX MESH (DEVICE 1) WAS TACKED DOWN TO THE FASCIA." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO BARD FLAT MESH (DEVICE 2 AND DEVICE 3). PER OP NOTES, "TWO BARD FLAT MESHES (DEVICE 2 AND 3) WERE PLACED TO THE ABDOMINAL WALL USING PROLENE SUTURES. A DULEX MESH (DEVICE 1) WAS EXPOSED." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH INFECTED ABDOMINAL WALL MESH THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE 1, 2 AND 3). PER OP NOTES, "THE UNDERLYING VISCERA WAS DENSELY ADHERENT TO IT. THE MESH (DEVICE 1, 2 AND 3) WERE REMOVED."

  Patient problems: Adhesion(s); Unspecified Infection

  MAUDE report 23943051 ↗
• InjuryDec 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO BARD FLAT MESHES (DEVICE 1 AND 2). PER OP NOTES, "A RIGHT GROIN INCISION WAS MADE, THE PREVIOUS SYNTHETIC MESH HAD PULLED AWAY FROM THE FASCIA. A BARD FLAT MESH (DEVICE 1) WAS PLACED USING SUTURES. AN INCISION WAS MADE THROUGH THE LEFT GROIN SCAR; THE PREVIOUS SYNTHETIC MESH HAD PULLED AWAY FROM THE FASCIA. A BARD FLAT MESH (DEVICE 2) WAS PLACED USING SUTURES." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO 3DMAX MESHES (DEVICE 3 AND 4). PER OP NOTES, "THE RIGHT INGUINAL HERNIA WAS SEEN, THE MESH (DEVICE 1) WAS FOUND. A 3DMAX MESH (DEVICE 3) WAS PLACED TO THE RIGHT PREPERITONEAL SPACE USING TACKS. ATTENTION TO THE LEFT SIDE, THERE WAS MESH (DEVICE 2) FREEING OF THE PERITONEUM AND DIRECT RECURRENCE WAS IDENTIFIED. A LEFT SIDED 3DMAX MESH (DEVICE 4) WAS PLACED TO THE LEFT PREPERITONEAL SPACE USING TACKS."

  Patient problems: Hernia

  MAUDE report 23786841 ↗
• InjuryDec 3, 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) (0112640) ON (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH) (B)(6). ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED UNSPECIFIED INJURY DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 20829208 ↗
• InjuryJul 5, 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/DAVOL MONOFILAMENT PP MESH (BARD FLAT MESH) ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE MONOFILAMENT PP 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 SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 19679932 ↗
• InjuryMay 6, 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) AND BARD/DAVOL MARLEX (BARD FLAT MESH) ON (B)(6) 2009 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; Pain

  MAUDE report 19247812 ↗
• InjuryJan 12, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY:29-JAN-2008 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA WAS IDENTIFIED AND REDUCED THROUGH INTERNAL RING. A SMALL PERFIX PLUG (DEVICE #1) WAS PLACED INTO THE EXTERNAL RING AND INTO INGUINAL CANAL AND SUTURED.¿23-MAR-2009 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #2). PER OPERATIVE NOTES, ¿THE DIRECT INGUINAL HERNIA WAS IDENTIFIED AND REDUCED. A PERFIX PLUG (DEVICE #2) WAS PLACED AND SUTURED.¿ (NOTE: THERE WAS NO VISUALIZATION OF PREVIOUS MESH).(B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RIGHT GROIN PAIN THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESHES AND IMPLANT OF BARD FLAT MESH (DEVICE #3). PER OPERATIVE NOTES, ¿ILIOINGUINAL AND ILIOHYPOGASTRIC NERVES WERE IDENTIFIED AND DIVIDED. THE ILIOINGUINAL NERVE HAD GONE INTO THE SCAR TISSUE. THE WADDED PIECE OF POLYPROPYLENE MESH (DEVICE #1 & DEVICE #2) WERE FREED AND REMOVED. A BARD FLAT MESH (DEVICE #3) WAS PLACED AND SUTURED.¿ 19-DEC-2011 - PATIENT WAS DIAGNOSED WITH CHRONIC LEFT GROIN PAIN WITH NERVE EN

  Patient problems: Nerve Damage; Neuralgia

  MAUDE report 18509308 ↗
• InjuryFeb 13, 2023Defective 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) PATCH ON (B)(6) 2020. 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: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 16363326 ↗
• InjuryNov 22, 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) 2009. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 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: Hernia; Insufficient Information; Pain

  MAUDE report 15841700 ↗
• InjuryNov 21, 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 FLAT MESH (BARD MESH) ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD FLAT MESH (BARD MESH). ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Insufficient Information; Scar Tissue

  MAUDE report 15833301 ↗
• InjuryJun 15, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD MESHES (BARD FLAT MESH) ON (B)(6) 2017 AND (B)(6) 2017. AS REPORTED THE PATIENT IS MAKING AN ADVERSE OUTCOME AGAINST BOTH THE DEVICES. 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: Hernia; Insufficient Information; Pain

  MAUDE report 14691799 ↗
• InjuryFeb 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 UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2014 AND BARD/DAVOL VENTRALIGHT ST MESH ON (B)(6) 2020. 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: Adhesion(s); Hernia; Insufficient Information

  MAUDE report 13522869 ↗
• InjuryDec 17, 2021Defective 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 UNSPECIFIED BARD MESH (BARD FLAT MESH) (X2) ON (B)(6) 2016 AND (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. 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 13023873 ↗
• InjuryDec 17, 2021Defective 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 UNSPECIFIED BARD MESH (BARD FLAT MESH) (X2) ON (B)(6) 2016 AND (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC LEFT INGUINAL 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) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE #2). PER OP NOTES, "A BARD FLAT MESH (DEVICE #2) WAS PLACED AND SUTURED." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC-ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF UNKNOWN MESH. PER OP NOTES,

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 13023871 ↗
• InjuryDec 7, 2021Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD MESHES (BARD FLAT MESH) ON (B)(6) 1998 AND (B)(6) 2000. 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: Hernia; Insufficient Information

  MAUDE report 12951713 ↗
• InjuryNov 17, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT AN OPEN LEFT INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2011 AND WAS IMPLANTED WITH A BARD FLAT MESH. IT WAS REPORTED THAT IN 2017, THE PATIENT CONTACTED THE DOCTOR AND REPORTED PAIN AT THE HERNIA MESH SITE. THE PATIENT WAS ADVISED TO COME INTO THE OFFICE FOR FOLLOW-UP TO HAVE ULTRASOUND AND OTHER DIAGNOSTIC TESTS. THE PATIENT DID NOT COMPLY. IN 2019 THE PATIENT CALLED THE DOCTOR¿S OFFICE WITH THE SAME COMPLAINT BUT, AGAIN, DID NOT SCHEDULE A FOLLOW-UP APPOINTMENT OR TESTING. AS REPORTED BY THE DOCTOR¿S OFFICE THE PATIENT DOES NOT HAVE A SCHEDULED APPOINTMENT AT THIS TIME.

  Patient problems: Pain

  MAUDE report 12827883 ↗
• InjuryOct 27, 2021Defective 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 THE IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2003. 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: Fibrosis; Hernia; Insufficient Information; Nerve Damage; Pain; Scar Tissue

  MAUDE report 12702372 ↗
• InjuryJul 7, 2021Defective 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) 2007. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH). IT IS ALLEGED THAT FROM (B)(6) 2017, THE PATIENT BEGAN TO SUFFER FROM PAIN, RECURRENCE AND BOWEL INCARCERATION. 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: Hernia; Insufficient Information; Pain; Scar Tissue

  MAUDE report 12131319 ↗
• InjuryMar 30, 2021Defective 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) 2016. 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 11587444 ↗
• InjuryMar 22, 2021Defective 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 TWO UNSPECIFIED BARD/DAVOL MARLEX (BARD FLAT MESH) ON (B)(6) 2004 AND (B)(6) 2006. 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: Hernia; Insufficient Information; Seroma

  MAUDE report 11537296 ↗
• InjuryFeb 5, 2021Defective 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 MESH (BARD FLAT MESH) AND BARD/DAVOL PERFIX PLUG ON (B)(6) 2015 AND/OR (B)(6) 2016 (X2). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL 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: Hernia; Injury

  MAUDE report 11284052 ↗
• InjuryDec 16, 2020Defective Device; Material Deformation; Material Protrusion/Extrusion; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Material Deformation; Material Protrusion/Extrusion; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2011, THE PATIENT HAD SURGERY ON THE ABDOMEN AND A BARD/DAVOL FLAT MESH WAS INSTALLED, ALONG WITH A NON-BARD/DAVOL PRODUCT AND UTILIZING NON-BARD/DAVOL SUTURE CLIPS TO TREAT STRESS PELVIC FLOOR PROLAPSE. THE PATIENT HAD THE MESH REMOVED ON (B)(6) 2019. IT IS ALLEGED THAT AS A RESULT OF THE PELVIC MESH PRODUCTS, THE PATIENT HAS SUSTAINED PERMANENT INJURY, AND HAS EXPERIENCED AND WILL CONTINUE TO EXPERIENCE SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING. IT IS ALSO ALLEGED THAT THE INJURIES, CONDITIONS AND COMPLICATIONS SUFFERED BY THE PATIENT DUE TO THE PELVIC MESH PRODUCTS INCLUDE BUT ARE NOT LIMITED TO MESH EROSION, MESH EXPOSURE, MESH CONTRACTION, INFECTION, INFLAMMATION, SCAR TISSUE, ORGAN PERFORATION, DYSPAREUNIA, BLOOD LOSS, PELVIC FLOOR DAMAGE, PELVIC PAIN, AND RECURRENT URINARY INCONTINENCE. IT IS ALLEGED THAT THE PATIENT WAS HURT, INJURED, SUSTAINED INJURY TO THE NERVOUS SYSTEM WHICH HAVE CAUSED GREAT MENTAL, PHYSICAL AND NERVOUS PAIN AND SUFFERING AND SOME PERMANENT DISABILITY. IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE. ADDENDUM: PER INFORMATION PROVIDED IN THE MEDICAL RECORDS: (B)(6) 2011 - A 48-YEAR-OLD FEMALE, WITH A H

  Patient problems: Disability; Erosion; Internal Organ Perforation; Nervous System Injury; Unspecified Infection

  MAUDE report 11023484 ↗