BARD 0112650Recalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 00801741016509), received between Apr 10, 2017 and May 19, 2026 — classified as 109 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 110 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2020- PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿THE LARGE DIRECT HERNIA SAC WAS IDENTIFIED IN LEFT INGUINAL REGION AND WAS REDUCED. A BARD FLAT MESH (DEVICE 1) WAS PLACED AND SUTURED TO THE INGUINAL LIGAMENT¿. ON (B)(6) 2021 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 2). PER OP NOTES, ¿THE OLD MESH (DEVICE 1) AND A SMALL RECURRENCE WAS NOTED PROXIMALLY. A BARD FLAT MESH (DEVICE 2) WAS THEN SUTURED TO THE INTERNAL LIGAMENT¿. ON (B)(6) 2022- PATIENT HAD LEFT INGUINAL HERNIA REPAIR BY LAPAROSCOPIC REPAIR.

  Patient problems: Hernia

  MAUDE report 25214303 ↗
• InjuryMar 4, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿A LARGE HERNIA SAC WAS NOTED AND DISSECTED OUT. THE CONTENTS OF HERNIA WERE REDUCED. A PORTION OF SIGMOID COLON ADHERENT TO HERNIA SAC WAS TAKEN DOWN. A BARD FLAT MESH (DEVICE 1) WAS PLACED AND SECURED USING SUTURES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX (DEVICE 2). PER OP NOTES, ¿ON THE RIGHT INGUINAL REGION, THERE WAS EVIDENCE OF PRIOR MESH AND NO HERNIA NOTED. ON THE LEFT INGUINAL REGION, THE PRIOR MESH (DEVICE 1) WAS NOTED. AN INDIRECT HERNIA SAC WITH BOWEL WAS NOTED AND REDUCED. THE HERNIA SAC WAS DISSECTED OFF. A 3DMAX (DEVICE 2) WAS PLACED AND SECURED USING SUTURES.¿ (NOTE: THE MESH NOTED IN RIGHT GROIN WAS UNKNOWN) (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH MULTIPLE RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿MILD ADHESIONS OF PREVIOUS REPAIR WERE TAKEN DOWN. ON THE LEFT INGUINAL REGION, A LARGE INDIRECT HERNIA WAS NOTED W

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24506454 ↗
• InjuryFeb 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1) AND BARD FLAT MESH (DEVICE 2). PER OP NOTES, ¿A VERY THICK-WALLED HERNIA SAC EXTENDING DOWN TO THE LEVEL OF THE SCROTUM WAS VISUALIZED. A PERFIX PLUG (DEVICE 1) WAS PLACED AND SUTURED TO THE MUSCULATURE OF THE INTERNAL RING AND ONLAY BARD FLAT MESH (DEVICE 2) WAS PLACED IN THE FLOOR OF INGUINAL CANAL TO REINFORCE THE REPAIR USING SUTURES.¿ ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT DIRECT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿A VERY LARGE RECURRENT DIRECT INGUINAL HERNIA WAS INCARCERATED WITH OMENTUM. ADHESIONS WERE TAKEN DOWN. THE LARGE PLUG (DEVICE 1) HAD DETACHED FROM INGUINAL LIGAMENT. IN A MODIFIED SHOULDICE FASHION, REATTACHED THE PREVIOUS MESH TO INGUINAL LIGAMENT AND CLOSED THE FLOOR USING SUTURES.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24376062 ↗
• InjuryNov 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2001 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, "AN INCISION WAS MADE IN THE LEFT GROIN, A PERFIX PLUG (DEVICE 1) WAS PLACED USING PROLENE SUTURES." (B)(6) 2002 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 2) AND UMBILICAL HERNIA REPAIR WITH MARLEX MESH. PER OP NOTES, "AN INCISION WAS MADE IN THE LEFT GROIN, THE PREVIOUS MESH PLUG (DEVICE 1) WAS FOUND AND PLACED AN ANOTHER PERFIX PLUG (DEVICE 2). ATTENTION TO THE UMBILICUS, THE UMBILICUS WAS REPAIRED WITH UNKNOWN MARLEX MESH." (B)(6) 2002 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 3). PER OP NOTES, "AN INCISION WAS MADE IN THE OLD WOUND, AND DISSECTION WAS CARRIED OUT. A BARD FLAT MESH (DEVICE 3) WAS PLACED." (NOTE: THE PREVIOUSLY PLACED PERFIX PLUG (DEVICE 2) WAS NOT SEEN DURING THIS PROCEDURE). (B)(6) 2002 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT REPAIR THE IMPLANT OF SYNTHETIC MESH. PER OP NOTES

  Patient problems: Hernia

  MAUDE report 23542261 ↗
• InjuryJul 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1, #2). PER OP NOTES, ¿THE BARD FLAT MESH (DEVICE #1) WAS SEWN IN PLACE ALONG THE SHELVING BORDER LATERALLY AND MEDIALLY TACKED TO TRANSVERSALIS FASCIA, THE SECOND PIECE OF BARD FLAT MESH (DEVICE #2) WAS ADDED TO LENGTH OF DEFECT.¿ ON (B)(6) 2015 ¿ PATIENT HAD FLUID COLLECTION IN LEFT GROIN THEREBY UNDERWENT INCISION AND DRAINAGE OF LEFT GROIN WOUND. ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH LEFT GROIN ABSCESS THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESHES (DEVICE #1, #2). PER OP NOTES, ¿THERE WAS SOME NECROTIC FAT AND INCORPORATED MESH (DEVICE #1, #2) WHICH WERE EXCISED TO ITS FULLEST EXTENT.¿

  Patient problems: Abscess; Necrosis

  MAUDE report 22381754 ↗
• InjuryMay 2, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS DISSECTED. A BARD FLAT MESH (DEVICE #1) WAS PLACED AND SECURE IT WITH SUTURE.¿ ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH VERY LARGE RIGHT INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE #2). PER OPERATIVE NOTES, ¿A LARGE BULGE WAS BENEATH THE ABDOMINAL WALL. THE HUGE HERNIA SAC WAS THEN DISSECTED. A BARD FLAT MESH (DEVICE #2) WAS PLACED AND SECURE IT WITH SUTURE.¿ ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH CHRONIC INFECTED MESH THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF BARD FLAT MESH (DEVICE #2). PER OPERATIVE NOTES, ¿HISTIOCYTIC INFLAMMATION AND APONEUROSIS WAS THERE. A TRANSVERSE INCISION WAS MADE. THE INFECTED BARD FLAT MESH (DEVICE #2) WAS THEN DISSECTED.¿ ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH NONHEALING ABDOMINAL WOUND THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF THE BARD FLAT MESH (DEVICE #1). PER OPERATIVE NOTES, ¿BARD FLAT MESH (DEVICE #1) AND THE SUTURES WERE EXCISED FROM THE WOUND. THE WOUND WAS TH

  Patient problems: Fibrosis; Impaired Healing; Inflammation; Unspecified Infection

  MAUDE report 21949403 ↗
• MalfunctionApr 24, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, WITHIN THE STERILE PACKAGE OF A BARD FLAT MESH, A FOREIGN MATERIAL THAT LOOKED LIKE A ¿HAIR¿ WAS NOTED TO BE PRESENT. IT WAS REPORTED THAT THE ISSUE WAS NOTICED DURING INVENTORY INSPECTION AND WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901399 ↗
• InjuryMar 28, 2025Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD FLAT MESH ON (B)(6)1997. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 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); Insufficient Information; Pain

  MAUDE report 21716959 ↗
• InjuryFeb 13, 2025Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  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 RI

  Patient problems: Adhesion(s); Fibrosis; Hernia; Inflammation; Necrosis

  MAUDE report 21373038 ↗
• InjuryFeb 5, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT HAD EVISCERATION OF PREVIOUSLY REPAIRED VENTRAL HERNIA. THE PATIENT WAS IN THE OPERATING ROOM, BEGAN TO COUGH VERY VIOLENTLY AFTER BEING EXTUBATED RESULTING IN HERNIA THAT WAS DONE WITH ALL OF THE STITCHES BROKEN. AN OPEN REPAIR WAS THEN PERFORMED WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1, #2). PER OPERATIVE NOTES, ¿THEN OMENTUM WAS REDUCED INTO THE ABDOMINAL CAVITY. THE FASCIAL RING WAS IDENTIFIED, AND BARD FLAT MESH (DEVICE #1, #2) WAS PLACED AT THE SITE WITH INTERRUPTED SUTURES. ¿-13 (NOTE: DEVICE #1, #2 HAVE BEEN CONSIDERED BASED ON THE TWO IMPLANT STICKERS PROVIDED). (B)(6) 2015 - PATIENT HAD RECURRENT INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE #3). PER OPERATIVE NOTES, ¿THE HERNIA BULGE WAS OPENED AND INTERNAL ADHESIONS TO THE OMENTUM WERE PEELED AWAY. THERE WAS SOME OLD MESH (DEVICE #1) IN THE INFERIOR ASPECT OF THE REPAIR SITE GOING DOWN TOWARDS THE UMBILICUS FROM A PRIOR HERNIA REPAIR. AN OVAL SHEET OF VENTRALIGHT ST MESH (DEVICE #3) WAS THEN INSERTED INTO THE ABDOMINAL CAVITY UNDER THE ABDOMINAL WALL WITH THE COATED SIDE DOWN AGAINST THE BOWEL USING SUTURE.¿ AT

  Patient problems: Adhesion(s); Hernia

  MAUDE report 21312493 ↗
• InjuryDec 3, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1 & DEVICE #2). PER OPERATIVE NOTES, ¿AN OLD UNKNOWN MESH WAS COMPLETELY REMOVED. A LARGE DIRECT LEFT INGUINAL HERNIA WAS IDENTIFIED. THEN A LARGE PLUG (DEVICE #1) WAS TACKED TO THE COOPER LIGAMENT AND THE ONLAY PATCH WAS PLACED OVER THE TOP OF THE PUBIC TUBERCLE. A LARGE DIRECT RIGHT INGUINAL HERNIA WAS IDENTIFIED. THEN A PLUG (DEVICE #2) WAS TACKED TO THE COOPER LIGAMENT AND AN ONLAY PATCH WAS PLACED OVER THE TOP OF THE PUBIC TUBERCLE.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #3) AND REMOVAL OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿RECURRENT LEFT INGUINAL HERNIA WAS IDENTIFIED. THEN A PERFIX PLUG (DEVICE #1) WAS REMOVED. A PIECE OF MARLEX MESH (DEVICE #3) WAS PLACED OVER THE TOP AND SECURED BY SUTURES.¿ (THERE WAS NO VISUALIZATION/MENTION OF PERFIX PLUG (DEVICE #2)). (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR. PER OPERATIVE

  Patient problems: Hernia

  MAUDE report 20830965 ↗
• 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) 2011. 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 19759392 ↗
• InjuryJun 27, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT UNDERWENT A TWO-PART PROCEDURE ON (B)(6) 2021 WHICH INCLUDED A BILATERAL DIRECT INGUINAL HERNIA REPAIR WITH IMPLANT OF A BARD FLAT MESH CUT INTO TWO PIECES AND USED ON BOTH THE RIGHT AND LEFT GROIN; A UROLIFT SYSTEM PROCEDURE FOR ENLARGED PROSTATE WITH IMPLANT ON NON-BARD/BD SUTURE/METAL IMPLANTS. AS REPORTED ABOUT ONE YEAR POST IMPLANT PATIENT STARTED TO EXPERIENCE A RASH ALL OVER HIS LEGS, FEET, AND ABDOMINAL AREA AROUND HIS UMBILICUS, EXPERIENCING EXCRUCIATING PAIN ON THE BOTTOM OF HIS FEET AND SKIN BURNING. IT WAS REPORTED THAT THE PATIENT HAS HAD CELLULITIS ON NUMEROUS OCCASIONS ON HIS LEGS AND FEET. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE TESTING (CT SCAN AND MIRS) AND AS REPORTED PER PATIENT'S ALLERGIST, "PATIENT DEVELOPED A HORRIFIC RASH THAT HAS NOT BEEN RESPONSIVE TO ANY SIGNIFICANT TREATMENT SINCE HE HAD THE MESH PLACE.".

  Patient problems: Pain; Rash; Skin Burning Sensation

  MAUDE report 19625394 ↗
• 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: Hernia; Insufficient Information; Pain; Scar Tissue

  MAUDE report 19247814 ↗
• InjuryFeb 15, 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) 2020. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT BARD FLAT MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA DEFECT WAS IDENTIFIED AND CLOSED WITH SUTURES. A BARD FLAT MESH (DEVICE #1) WAS PLACED AND SECURED WITH SUTURES.¿ ON (B)(6) 2023 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF BARD FLAT MESH (DEVICE #1) AND IMPLANT OF VENTRALEX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE HERNIA WAS NOTED. THE MESH WAS SEEN ADHERENT TO THE HERNIA SAC AND OMENTUM. THE HERNIA SAC AND PREVIOUSLY PLACED MESH (DEVICE #1) WAS REMOVED. THE VENTRALEX MESH (DEVICE #2) WAS PLACED UNDERNEATH THE FASCIA AND SECURED WITH SUTURES.

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

  MAUDE report 18710006 ↗
• InjuryAug 28, 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 IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2019. 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: Adhesion(s); Hernia; Insufficient Information

  MAUDE report 17629891 ↗
• InjuryNov 4, 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) 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 SUSTAINED UNSPECIFIED INJURY 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 15735818 ↗
• InjuryJun 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) AND BARD/DAVOL VENTRALEX ON (B)(6) 2011 AND/OR (B)(6) 2012. 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 14685776 ↗
• InjuryMay 12, 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 MESH (BARD FLAT MESH) ON (B)(6) 1999. 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; Cellulitis; Insufficient Information; Necrosis

  MAUDE report 14367077 ↗
• InjuryMar 23, 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) 2019. 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: Hernia; Insufficient Information; Pain

  MAUDE report 13863393 ↗
• InjuryJan 12, 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) 2012 AND BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2018. 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: Hernia; Insufficient Information; Pain

  MAUDE report 13234303 ↗
• InjuryJan 3, 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 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 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)2021 - Patient was diagnosed with left inguinal hernia thereby underwent open repair with the implant of Bard Flat Mesh. Per op notes, "An incision was made carried over the left inguinal canal. The Bard Flat Mesh was placed to the floor of the canal using sutures." (b)(6)2021 - Patient was diagnosed with infected mesh thereby underwent repair with removal of infected mesh. Per op notes, "An incision was made around the left inguinal region. There was a draining sinus in the middle of an old scar. Began to excise mesh from adherent tissue and the mesh was removed. A biologic mesh was placed

  Patient problems: Adhesion(s); Insufficient Information; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 13142129 ↗
• InjuryDec 23, 2021Defective Device; Patient Device Interaction Problem; Migration; Defective Device; 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) 2010. 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: Abscess; Insufficient Information; Pain; Unspecified Infection

  MAUDE report 13076516 ↗
• InjuryDec 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 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: Insufficient Information; Pain

  MAUDE report 12958045 ↗
• 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 IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2006 AND BARD/DAVOL PERFIX PLUG ON (B)(6) 2008. 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 12708866 ↗